BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2897039 · Received January 4, 2013

    Report

    Report Number
    9614453-2013-00008
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 7428 SERIAL # (B)(4) DETERMINED THAT THE BATTERY DID NOT MEET ITS LONGEVITY ESTIMATE. THERE WAS NO TELEMETRY (NO OUTPUT) OBSERVED ON THE INITIAL REVIEW FINDINGS WHEN ALL ELECTRODES WERE REFERENCED TO ONE ELECTRODE. IT WAS NOTED THAT THE BATTERY WAS EXPANDED. NO ANOMALIES WERE FOUND ON THE DEVICE INTERNAL VISUAL INSPECTION. THE HYBRID OUTPUT TEST RESULTS SHOWED THAT THE OUTPUT MATCHED THE SETTINGS. THE BATTERY VOLTAGE WAS AT 1.38 VOLTS AND WAS REPORTED TO BE NORMAL DEPLETION OF THE INS BATTERY. THE INS LONGEVITY ESTIMATE FOR ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 61.2 MONTHS AND FOR END-OF-SERVICE (EOS) 64.4 MONTHS. HOWEVER, THIS INS REACHED THE EOS AT 20.7 MONTHS WHICH INDICATED THAT THE BATTERY DID NOT MEET THE LONGEVITY ESTIMATED FOR THIS DEVICE, WITH THE CAUSE OF THE PREMATURE DEPLETION REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SUSPECTED EARLY BATTERY DEPLETION. THE REPORTER STATED THAT THE PATIENT'S DEVICE WAS AT EOL (END OF LIFE) WITH A BATTERY VOLTAGE OF 2.12 VOLTS. PROGRAMMING PARAMETERS FOR BOTH THE RIGHT AND LEFT SIDES WERE 60 MICROSECONDS, 130 HERTZ, AND 2.7 VOLTS. PATIENT SYMPTOMS INCLUDED LESS THAN 50 PERCENT THERAPY RELIEF. IT WAS REPORTED THAT A REPLACEMENT WOULD BE DONE IN (B)(6) 2013. IT WAS NOTED THAT THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION REPORTED THAT BASED ON THE PROGRAMMING PARAMETERS, THE LONGEVITY OF THE BATTERY WAS 2.68 YEARS. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. THE PHYSICIAN FELT THAT 2 OF THE SET SCREWS WERE NOT COMPLETELY TIGHT. IMPEDANCES WITH THE NEW INS WERE WITHIN NORMAL RANGE. THE PATIENT OUTCOME WAS REPORTED AS 'OK'. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4871 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention