PERMANENT PACEMAKER ELECTRODE Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)

Total Reports

4,688

Reports (30d)

0

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

System Revision Due to Infection

adverse, infection, revision, effects, implantable

4

reports

2

Revision Due to Infection

infection, effects, revision, reported lead, additional adverse

3

reports

3

Loss of Capture in RA Lead

capture, loss, adverse, impedance, effects

2

reports

4

Low Pacing Impedance in RA Lead

defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator

2

reports

5

Noise Oversensing in RV Lead

noise, right ventricular, use right, ventricular lead, oversensing

1

reports

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

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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.