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2026 data FDA MAUDE openFDA FDA Class III

Pulse Generator, Permanent, Implantable

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Pulse Generator, Permanent, Implantable MID-BOOK · MAUDE

#40 of 1000 · 95,144 reports · 1997–2026

  • BOOK 95,144 reports
  • RANK #40 of 1000
  • DEATH 3,912 death-typed
  • INJ 49,618 injury-typed
  • MALF 41,412 malfunction
  • SPAN 1997–2026
  • PEAK 2021: 8,538
  • PHOTO Bed

Nearest event-volume peer: Bed, Ac-Powered Adjustable Hospital (1,370 report gap)

Pulse Generator, Permanent, Implantable sits #40 of 1000 among tracked device types with 95,144 MAUDE reports spanning 1997–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Pulse Generator, Permanent, Implantable carries 52.2% INJURY-coded reports, 21.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.1% corpus 1.5% · above corpus mean (+2.6 pp)
  • INJ 52.2% corpus 30.3% · above corpus mean (+21.9 pp)
  • MALF 43.5% corpus 64.8% · below corpus mean (-21.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 20% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Pulse Generator, Permanent, Implantable in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Pulse Generator, Permanent, Implantable carries 95,144 MAUDE reports, ranked #40 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 49,618 (52.2%)
Malfunction 41,412 (43.5%)
Death 3,912 (4.1%)
Other 140 (0.1%)
62 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

34,254 (27.5%)
Hospitalization 26,846 (21.5%)
R 21,509 (17.3%)
Required Intervention 21,482 (17.2%)
Other 5,690 (4.6%)
H 4,896 (3.9%)
Death 3,887 (3.1%)
L 3,137 (2.5%)
Life Threatening 2,380 (1.9%)
O 434 (0.3%)
D 50 (0.0%)
Congenital Anomaly 19 (0.0%)
S 16 (0.0%)
Disability 3 (0.0%)
C 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 19,056
Premature Discharge of Battery 10,736
Pacing Problem 9,992
Appropriate Device Problem Term/Code Not Available 8,053
Over-Sensing 5,349
Battery Problem 4,482
Failure to Interrogate 4,344
Mechanical Problem 3,706
Failure to Capture 3,260
Inappropriate or Unexpected Reset 1,851
Unable to Obtain Readings 1,784
Insufficient Device Problem Information 1,770
Device Dislodged or Dislocated 1,663
High impedance 1,613
Incorrect Measurement 1,566
Communication or Transmission Problem 1,462
Pacemaker Found in Back-Up Mode 1,376
Reset Problem 1,316
Inappropriate/Inadequate Shock/Stimulation 1,308
Defective Device 1,297

Yearly Trend

97
1997: 4
03
2003: 1
04
2004: 7
05
2005: 10
06
2006: 39
07
2007: 85
08
2008: 142
09
2009: 245
10
2010: 4,039
11
2011: 6,334
12
2012: 5,562
13
2013: 4,033
14
2014: 3,107
15
2015: 2,773
16
2016: 2,558
17
2017: 3,164
18
2018: 5,878
19
2019: 8,188
20
2020: 8,337
21
2021: 8,538
22
2022: 7,791
23
2023: 8,463
24
2024: 6,496
25
2025: 6,060
26
2026: 3,290

Reports in 2025 (6,060) held close to the prior two-year average of 7,480.

Related Entities for Pulse Generator, Permanent, Implantable

Top Manufacturers

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 16,023
MEDTRONIC PUERTO RICO OPERATIONS CO. 15,159
MEDTRONIC SINGAPORE OPERATIONS 14,142
MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7,863
BIOTRONIK SE & CO. KG 6,596
MEDTRONIC EUROPE SARL 5,392
GUIDANT CRM CLONMEL IRELAND 4,385
MEDTRONIC MED REL, INC. 3,989
IPG MFG SWITZERLAND 3,084
MEDTRONIC, INC. 2,601

Event Locations

47,556 (50.0%)
I 36,875 (38.8%)
HOSPITAL 9,897 (10.4%)
HOME 483 (0.5%)
OTHER 132 (0.1%)
NO INFORMATION 110 (0.1%)
OUTPATIENT TREATMENT FACILITY 52 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 11 (0.0%)
PATIENT'S HOME 9 (0.0%)
CLINIC - WALK IN, OTHER 5 (0.0%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
NURSING HOME 3 (0.0%)
UNKNOWN 2 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
PUBLIC BUILDING 1 (0.0%)
URGENT CARE CENTER 1 (0.0%)

Compare ST. JUDE MEDICAL, INC.(CRM-SYLMAR) vs MEDTRONIC PUERTO RICO OPERATIONS CO. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pulse Generator, Permanent, Implantable: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (95,144 here).

Bed, Ac-Powered Adjustable Hospital 93,774 Cabinet, Table And Tray, Anesthesia 97,989 System 90,606 Prosthesis 89,781

Similar death-typed counts

Nearest other device types by death-typed report count (3,912 here), distinct from the volume row.

Wearable Automated External Defibrillator 3,738 System, Peritoneal, Automatic Delivery 3,434 Automated External Defibrillators 4,510 Ventilator, Non-Continuous 4,569

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Pulse Generator, Permanent, Implantable are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Pulse Generator, Permanent, Implantable; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.