BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5997335 · Received October 4, 2016

    Report

    Report Number
    9614453-2016-05783
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 4, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR FOR DEEP BRAIN STIMULATION WITH A RETURN OF PARKINSON'S DISEASE SYMPTOMS SINCE THE MONTH PRIOR TO THIS REPORT. THE PATIENT COULD NOT WALK AND THEY WERE IN A WHEELCHAIR. DURING THE LAST FOLLOW-UP APPOINTMENT, PROGRAMMING REVEALED HIGH THERAPY IMPEDANCES. IMPEDANCES WERE MEASURED TO BE THE FOLLOWING: C-0 = 12308, C-2 = 15320, 0-1 = 10781, 0-3 = 31119, AND 0-3 = 10971 OHMS. IT WAS UNKNOWN WHAT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN TRIED TO INCREASE THE VOLTAGE BUT THE STIMULATION REMAINED THE SAME. AN X-RAY WILL BE PLANNED AS SOON AS POSSIBLE AND, AFTER THIS, THE PHYSICIAN WILL DECIDE IF A DBS SYSTEM REVISION WOULD BE NECESSARY. THE ISSUE WAS NOT RESOLVED AND THE PATIENT WAS ALIVE WITH NO INJURY. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647505 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1