BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2925512 · Received January 22, 2013

    Report

    Report Number
    9614453-2013-00023
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    September 22, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE AN ERI (EARLY REPLACEMENT INDICATOR) AFTER SIX MONTHS OF IMPLANT. THE REPORTER STATED THAT ACCORDING TO A LONGEVITY CALCULATION, THE DEVICE SHOULD NORMALLY GIVE THERAPY FOR AROUND 22 MONTHS. IT WAS NOTED THAT BIPOLAR IMPEDANCE SETTINGS WERE LOWER THAN MONOPOLAR IMPEDANCE SETTINGS AND THE PAIR OF THE CASE AND ELECTRODE 0 HAD A HIGH IMPEDANCE OF 4538 OHMS. ELECTRODE PAIR 5 AND 7 HAD A LOW IMPEDANCE OF 125 OHMS. IT WAS REPORTED THAT EXTENDED TROUBLESHOOTING WAS PERFORMED AND "SENT FOR ANALYSIS." THE REPORTER STATED THAT THE DEVICE WOULD HAVE TO BE REPLACED BECAUSE IT WAS EMPTY. IT WAS NOTED THAT THE PATIENT "STILL HAD GOOD THERAPY" AND WANTED TO KEEP THE THERAPEUTIC EFFECT. THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29233 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1