BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10779264 · Received November 3, 2020

    Report

    Report Number
    2182207-2020-01195
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 16, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INS BATTERY DEPLETED ONE AND A HALF YEARS AFTER IMPLANT AND WAS SHOWING ERI. THIS WAS CONSIDERED A FAST DEPLETION FOR THE PATIENT. IN ADDITION, THERE WERE LOW IMPEDANCES. NO FACTORS WERE KNOWN TO HAVE LED OR CONTRIBUTED TO THE ISSUE. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. NO ACTIONS/INTERVENTIONS WERE TAKEN. THE ISSUE REMAINED UNRESOLVED AT THE TIME OF THE REPORT. (B)(6) 2020 (FOR, HCP, REP): ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS AN ALLEGATION OF EARLY/PREMATURE BATTERY DEPLETION. THE SETTINGS WERE IDENTIFIED AS DOUBLE MONOPOLAR CONTACT 1 AND 2, 2.3 V 60 US, 180 HZ. A REPLACEMENT HAS NOT YET BEEN PLANNED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244215 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1