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N/A PA96000Recalls & reported problems

Medtronic, Inc. · ACTV PA96000 PA US · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169571129), received between Apr 25, 2018 and Apr 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Emits Odor1
  • Overheating of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2018Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

    IT WAS REPORTED THAT THE PATIENT ACTIVATOR BATTERY WAS MELTING THE PLASTIC AND WAS DEVELOPING A HOLE AROUND THE BATTERY AREA ALSO HAD A SMELL OF BURNT PLASTIC. THE PATIENT WAS ADVISED TO DISPOSE THE PATIENT ACTIVATOR CORRECTLY. THE PATIENT ACTIVATOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7460043 ↗

Other DETECTOR AND ALARM, ARRHYTHMIA devices

All DETECTOR AND ALARM, ARRHYTHMIA devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.