BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1190324 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06350
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    May 13, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIMULATOR WAS RETURNED FOR ANALYSIS. EVALUATION RESULTS: DEVICE ANALYSIS REVEALED BROKEN WELD(S) AT THE BOND WIRE PAD(S)- LIFTED BOND WIRE PAD(S). UPON OPENING UP THE STIMULATOR, THE CASE FEED THROUGH WIRE WAS CONFIRMED TO BE LIFTED. THE EPOXY BONDS WERE BROKEN AT BOTH B+ AND B- TERMINALS. THE #2 & #3 FEED TROUGH WIRES & B- BOND WIRES WERE ALSO LIFTED . LIKELY DUE TO PERFORMING THE DESTRUCTIVE ANALYSIS PROCESS. THE DEVICE WAS PLACED ON THE AUTOMATED TEST SYSTEM (ATS) TO TEST THE VARIOUS PROGRAMMABLE FEATURES AND OUTPUT RANGES. THE DEVICE FAILED THE AUTOMATED TEST CONSOLE; THERE WAS NO OUTPUT ON THE CASE. THERE WAS ACCEPTABLE, STABLE OUTPUT OBSERVED ON EACH ELECTRODE PAIR, EXCEPT WHEN USED IN UNIPOLAR MODE. THE BATTERY HAD EXPANDED. THE CONNECTOR BLOCK AND INSULATION WERE SCRATCHED. FOREIGN MATERIAL WAS FOUND IN THE CONNECTOR PORT(S).

    Description of Event or Problem · 1

    IMPEDANCE READINGS >2000 OHMS WAS REPORTED ON ALL OR SOME OF THE UNIPOLAR PAIRS. THE PATIENT EXPERIENCED A LACK OF EFFECT. NO FRACTURES WERE NOTED ON XRAY. THE NEUROSTIMULATOR WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE EXTENSION WAS ATTRIBUTED THE EVENT. THE NEUROSTIMULATOR AND EXTENSION WERE REPLACED. NO INJURY WAS REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA. REFER TO MANUFACTURER REPORT #3004209178200804234.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXTENSION MODEL 7482 LOT# NHU061556V IMPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU061555V IMPLANTED| EXPLANTED| LEAD MODEL 3387 LOT# J0437135V IMPLANTED| LOT# NFW122804H IMPLANTED| EXPLANTED| LEAD MODEL 3387 LOT# J0437239V IMPLANTED| EXPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7426