BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3090349 · Received May 2, 2013

    Report

    Report Number
    9614453-2013-01040
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    September 23, 2013
    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

    PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. A REQUEST HAS BEEN SUBMITTED TO CLARIFY THE IMPLANT DATE. THE IMPLANT DATE GIVEN, (B)(6) 2007 IS PRIOR TO THE DEVICE MANUFACTURER DATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE ¿ELECTRODES¿ REFERRED TO PREVIOUSLY ARE CLARIFIED TO BE LEADS. THE CAUSE OF DEATH WAS UNKNOWN AS OF (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PATIENT'S ROUTINE FOLLOW UP ON (B)(6) 2013 THE BATTERY WAS FOUND TO BE DEPLETED AND A CT SCAN SHOWED THAT BOTH ELECTRODES HAD MOVED SIGNIFICANTLY. THE PATIENT WAS DOING WELL WITHOUT STIMULATION AND WAS GOING TO BE RE-EVALUATED IN MAY. IT WAS NOTED THAT THE PATIENT HAD BEEN DOING WELL SINCE THE DEVICE WAS IMPLANTED. THE PATIENT EXPIRED ON (B)(6) 2013. THERE WAS NO ALLEGATION TO THE DEVICE SYSTEM IN RELATION THE CAUSE OF DEATH. AN AUTOPSY WAS PERFORMED AND THE FINDINGS WERE UNASCERTAINED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192091 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR