BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2402182 · Received January 6, 2012

    Report

    Report Number
    9614453-2012-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INS MODEL 7426 (B)(4) IMPLANTED: UNK EXPLANTED: UNK, LEAD KIT MODEL 3389-28 LOT# V223871 IMPLANTED: UNK EXPLANTED: UNK, EXTENSION MODEL 748251 (B)(4) IMPLANTED: UNK EXPLANTED: UNK, EXTENSION MODEL 748251 (B)(4) IMPLANTED: UNK EXPLANTED: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL TO ADJUST SETTINGS BECAUSE THEIR PARKINSON'S DISEASE SYMPTOMS HAD WORSENED. IMPEDANCE TESTING FOUND VALUES GREATER THAN 2000 OHMS ON ELECTRODE PAIRS 0-1, 0-2, 0-3 AND 1-3. THE BATTERY VOLTAGE WAS GREATER THAN 3.9V, FOR ONE CASE. ONLY THE LEFT INS SHOWED ABNORMAL VALUES. IT WAS NOTED THAT THE PHYSICIAN THOUGHT THAT NEUROSTIMULATOR HAD SOMEHOW "FAILED." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THAT NO INTERVENTIONS WERE TAKEN, AND NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1