2002 data FDA MAUDE openFDA FDA Class I

Charger, Pacemaker

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §870.3670 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Charger, Pacemaker LIGHT-BOOK · MAUDE

#813 of 1000 · 626 reports · 1997–2002

  • BOOK 626 reports
  • RANK #813 of 1000
  • DEATH 22 death-typed
  • INJ 1 injury-typed
  • MALF 602 malfunction
  • SPAN 1997–2002
  • PEAK 2000: 392
  • PHOTO Nebulizer

Nearest event-volume peer: Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (3 report gap)

Charger, Pacemaker sits #813 of 1000 among tracked device types with 626 MAUDE reports spanning 1997–2002. 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 →

Malfunction reports run above the device-type norm

Charger, Pacemaker carries 96.2% MALFUNCTION-coded reports, 31.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.5% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
  • MALF 96.2% corpus 64.8% · above corpus mean (+31.3 pp)

Lead product-problem code Device Displays Incorrect Message is 21% of coded problems · Lead manufacturer ZOLL MEDICAL CORP. accounts for 74% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .

Charger, Pacemaker in the event-volume neighbourhood

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

reports

What this shows Charger, Pacemaker carries 626 MAUDE reports, ranked #813 of 1000.

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

Event Types

Malfunction 602 (96.2%)
Death 22 (3.5%)
1 (0.2%)
Injury 1 (0.2%)

Patient Outcomes

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

Other 598 (95.2%)
Death 25 (4.0%)
3 (0.5%)
O 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Device Displays Incorrect Message 177
No Display/Image 87
Failure to Power Up 75
Other (for use when an appropriate device code cannot be identified) 70
Failure to Discharge 57
Failure, intermittent 55
Replace 51
Pacing Problem 46
Failure to Charge 35
Blank screen 34
Device Issue 29
Out-Of-Box Failure 25
Defibrillation/Stimulation Problem 20
Display or Visual Feedback Problem 20
Noise 16
Pacing Inadequately 15
Loss of Power 14
EKG/ECG analysis, failure to perform 10
Failure to Analyze Signal 10
Program, failure to 10

Yearly Trend

97
1997: 3
98
1998: 21
99
1999: 208
00
2000: 392
01
2001: 1
02
2002: 1

Reports fell to 1 in 2001, down from an average of 300 in the two years before.

Related Entities for Charger, Pacemaker

Event Locations

618 (98.7%)
HOSPITAL 5 (0.8%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)

Compare ZOLL MEDICAL CORP. vs ZOLL MEDICAL CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

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

Disclaimer: MAUDE figures for Charger, Pacemaker 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 Charger, Pacemaker; 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.