BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2640323 · Received July 5, 2012

    Report

    Report Number
    3004209178-2012-05230
    Event Type
    Malfunction
    Date Received
    July 5, 2012
    Report Date
    June 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3387S-40 LOT# V230715 IMPLANTED: 2009-(B)(6) EXPLANTED: 2012-(B)(6); EXTENSION MODEL 7482A40 SERIAL# (B)(4) IMPLANTED: 2009-(B)(6) EXPLANTED: NA; PROGRAMMER MODEL 37642 SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3387S-40 LOT# V230715 SERIAL#, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. ANALYSIS OF THE LEAD, MODEL 3387S-40, FOUND THE LEAD BODY CONDUCTOR BROKEN WITHIN 10 CM OF CONNECTOR AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEAD REVISION DUE TO A FRACTURE ON ALL CONTACTS EXCEPT CASE AND 0. ALL OTHER ELECTRODE PAIR IMPEDANCES MEASURED ABOVE 2,000 OHMS. IT WAS NOTED THAT THIS WAS THE SECOND LEAD ON SAME SIDE THAT HAD TO BE REPLACED DUE TO FRACTURES (SEE MFR. REP. # 3004209178-2009-07470). THE FRACTURE WAS CONFIRMED THROUGH X-RAY, AND IT WAS REPORTED THAT REPROGRAMMING WASN'T AN OPTION. THERE WAS NO REPORTED TRAUMA ASSOCIATED WITH THE FRACTURED LEAD, AND THE CAUSE OF THE FRACTURE WAS NOT DETERMINED. THE PATIENT'S REVISION SURGERY WAS COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention