BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3221135 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11623
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 17, 2013
    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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL (B)(4)) FOUND THAT THE BATTERY WAS AT NORMAL END OF LIFE, AND THERE WAS NO TELEMETRY. THE BATTERY DID NOT SHOW ANY SIGNS OF AN INTERNAL SHORT OR ANY CAUSE FOR PRE-MATURE DEPLETION. NO PROBLEMS WERE FOUND WITH THE BATTERY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_WRENCH_ACC, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT STARTED TO ¿FEEL BAD¿ AND IT WAS FOUND THAT ¿THE SYSTEM RUN OUT OF BATTERY¿. THE BATTERY DEPLETION WAS NOT NORMAL. THE INS SYSTEM WAS REPLACED. EVERYTHING WAS WORKING NORMAL AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320509 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention