BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1366220 · Received March 19, 2009

    Report

    Report Number
    3004209178-2009-01954
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    July 1, 2008
    Report Date
    February 20, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0694-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER. FINAL DEVICE ANALYSIS RESULTS REVEALED - THE BATTERY HAD BROKEN WELDS AT THE BOND WIRE PADS (LIFTED BOND WIRES). THE CASE FEEDTHROUGH WIRE WAS LIFTED FROM THE HYBRID BOND PAD. THE EPOXY BOND WAS BROKEN BETWEEN THE HYBRID CIRCUIT AND BOTH BATTERY TERMINALS. THERE WAS FOREIGN MATERIAL IN THE CONNECTOR PORTS. THE INSULATION COATING AND TITANIUM CAN WAS SCRATCHED. THE IPG BATTERY VOLTAGE WAS 3.68 VOLTS. GOOD STABLE OUTPUT WAS OBSERVED ON ELECTRODES 0-3. NO OUTPUT WAS OBSERVED WHEN THE IPG WAS IN UNIPOLAR MODE. THE PRIMARY FINDING WAS - BROKEN WELDS AT THE BOND WIRE PADS (LIFTED BOND WIRES).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ABOUT SIX WEEKS AGO. ABOUT 10 DAYS PRIOR TO THE REPORT, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS SEEN IN THE CLINIC. THERE WAS IMPEDANCE READINGS >2000 OHMS ON SOME OR ALL BIPOLAR PAIRS (PAIRS WERE NOT SPECIFIED). THE PATIENT STATUS WAS REPORTED AS GOOD. THE HEALTHCARE PROVIDER WAS CONSIDERING FURTHER TROUBLESHOOTING. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT RECOVERED WITHOUT SEQUELA. REFERENCE MFR REPORT # 3004209178200806167.

    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 54 YR Required Intervention EXTENSION: MODEL 7495-51| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387| EXPLANTED:| LOT# NFW140743H| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED: