BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3233336 · Received July 18, 2013

    Report

    Report Number
    9614453-2013-01485
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    December 17, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT INITIALLY CHECKED THE IMPLANTABLE NEUROSTIMULATOR THE AMPLITUDE WAS SET TO 4.8 V FOR CH1 AND 6.3 V FOR CH2. WHEN THE PATIENT NEXT CHECKED THE DEVICE, THE AMPLITUDE WAS 4.0 V ON CH1 AND 5.5 V ON CH2. A NEW PATIENT PROGRAMMER WAS SENT TO THE PATIENT TO DETERMINE IF THE ISSUE RESIDED WITH THE PROGRAMMER, BUT THE OUTCOME WAS UNKNOWN. THERE WERE NO SYMPTOMS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334834 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1