BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4131790 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18051
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 9, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V556379, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V568687, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT THE PATIENT WAS OK FOR A WHILE. THE REPORTER ALSO MENTIONED THAT THE PATIENT WAS OK FOR A COUPLE OF MONTHS AFTER IMPLANT. THE PAST FOUR YEARS HAD BEEN A STRUGGLE. THE REPORTER STATED THAT WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED THE VOLTAGE WAS 2.64 OR 2.63. NO OUTCOME WAS REPORTED AS THE PATIENT HAD THE INS REPLACED AND HAD CONCERNS WITH NEW INS. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612974 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention