PERMANENT DEFIBRILLATOR ELECTRODES Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead)

Total Reports

2,314

Reports (30d)

0

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Gradual Rise in Shock Impedance Measurements

technical services, shock impedance, ohms, range, impedance measurements

2

reports

2

High Pace Impedance Measurements Noted

impedance measurements, measurements, remains service, effects, ohms

1

reports

3

High Shock Impedance in CRT-D System

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

1

reports

4

High Shock Impedance with Reprogramming Suggested

implantable cardioverter, icd, shock, technical services, defibrillator icd

1

reports

5

Implantable Lead Revision for Infection

implantable lead, effects, revision infection, reported implantable, lead revision

1

reports

6

Lead Capped for High Shock Impedance

patient events, received file, events reported, file updated, updated lead

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.