BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4960220 · Received August 3, 2015

    Report

    Report Number
    3004209178-2015-14492
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 10, 2015
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 64001, LOT# N475381, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3387S-40, LOT# V700663, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V727699, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-05, LOT# N293450, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT SHE HAD A LOSS OF THERAPY; HER "HAND DID NOT WANT TO HOLD ANYTHING" AND SHE HAD A LOSS OF STIMULATION IN THE AFTERNOON ON (B)(6) 2015. SHE NOTICED HER HAND DID NOT "FEEL RIGHT" AND THERE WERE NO CIRCUMSTANCES THAT LED TO THE ISSUE. SHE CHECKED HER IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PROGRAMMER AND IT WAS FOUND OFF. TURNING THE INS BACK ON RESOLVED THE ISSUE AND IT HAD NOT HAPPENED SINCE. REFER TO MANUFACTURING REPORT #3004209178-2015-14489 AS THE PATIENT HAD TWO INSS AND IT WAS NOT SPECIFIED WHICH ONE HAD TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505547 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR