MEDTRONIC MED REL, INC.

FDA MAUDE device safety record · 1996–2016

What the Data Shows About MEDTRONIC MED REL, INC.

MEDTRONIC MED REL, INC. is associated with 31,021 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1996 through 2016. Of the total, 3,390 are coded as death reports and 20,769 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 15 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MEDTRONIC MED REL, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 20,769 reports (67.0% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 18 years of MAUDE data, with the peak single-year volume reaching 9,672 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

31,021
Total Reports
3,390
Death Reports
20,769
Injury Reports
15
Device Types

Event Types

Injury 20,769 (67.0%)
Malfunction 6,787 (21.9%)
Death 3,390 (10.9%)
73 (0.2%)
Other 2 (0.0%)

Patient Outcomes

R 12,399 (27.1%)
Hospitalization 11,642 (25.4%)
Other 9,633 (21.0%)
Required Intervention 5,941 (13.0%)
Death 3,317 (7.2%)
O 1,254 (2.7%)
L 874 (1.9%)
Life Threatening 418 (0.9%)
H 229 (0.5%)
68 (0.1%)
D 13 (0.0%)
S 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

96
1996: 1
97
1997: 36
98
1998: 178
99
1999: 105
00
2000: 217
01
2001: 203
02
2002: 280
03
2003: 344
04
2004: 312
05
2005: 218
06
2006: 446
07
2007: 576
08
2008: 786
09
2009: 1,927
10
2010: 7,366
11
2011: 9,672
12
2012: 8,353
16
2016: 1

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.