BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2950731 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01493
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 28, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V187426, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V199170, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TURNED OFF ONE IMPLANTABLE NEUROSTIMULATOR (INS) 'KIND OF PERMANENTLY' DUE TO HAVING HAD ISSUES WITH IT. WHEN IT WAS 'RAMPED UP' THE PATIENT FELT THAT HE WAS BEING ELECTROCUTED. MULTIPLE 'TUNE UPS' WERE ATTEMPTED AND IT WAS DECIDED TO TURN IT OFF. THE DEVICE HAD BEEN OFF SINCE ABOUT 9-12 MONTHS AFTER IMPLANT.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT IT WAS THE RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS HAVING ISSUES, WHICH ¿WAS THE SIDE THAT WAS DISCONNECTED" INTENTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54767 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR