BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1080258 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04235
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 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 NEURO STIMULATOR WAS RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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 X-RAY. THE EXTENSION ATTRIBUTED TO THE EVENT. THE EXTENSION AND NEUROSTIMULATOR WERE REPLACED. THE NEUROSTIMULATOR WAS RETURNED FOR NORMAL BATTERY DEPLETION. NO INJURY WAS REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA. REFER TO MANUFACTURE REPORT #: 6000153-2008-02838.

    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 IMPLANTABLE NEURO STIMULATOR MODEL 7426| LEAD MODEL 3387| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482| EXPLANTED| LEAD MODEL 3387| EXPLANTED| EXTENSION MODEL 7482| EXPLANTED| LOT # NFW122533H