MEDTRONIC LEAD Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator

Total Reports

558

Reports (30d)

27

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Right Ventricular Lead Low Impedance Issues

right, impedance, lead exhibited, right ventricular, ventricular lead

13

reports

2

CIED Infections Leading to Patient Deaths

cardiovascular, patients, death, diagnosis, cied

9

reports

3

Inappropriate Device Therapy and Patient Deaths

devices, atrial, patients, inappropriate, death

9

reports

4

Periprocedural Complications in Pediatric Patients

groups, burden, patients, periprocedural complications, group

5

reports

5

Inappropriate Pacing from Right Atrial Undersensing

right, impedance, right ventricular, ventricular lead, device remains

1

reports

6

Premature Battery Depletion of Pulse Generator

battery, implantable pulse, pulse generator, generator ipg, ipg

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Active safety signals

Disproportionate reportinghigh

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.