BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3006444 · Received March 15, 2013

    Report

    Report Number
    3004209178-2013-03784
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    February 22, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37651 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3387S-40 LOT# V761180, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V761180, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE AND HIS CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING AN ELECTRIC SLIDING DOOR THAT HE WENT THROUGH ONE DAY AND IT WAS FINE, BUT WENT THROUGH BY THE EDGE OF IT THE SECOND DAY AND THE PATIENT'S DEVICE TURNED OFF. IT WAS STATED THAT THE PATIENT JUST TURNED IT RIGHT BACK ON AND IT WAS "FINE", AND THE PATIENT WAS WARNED THAT CERTAIN MACHINES COULD DO THAT. IT WAS NOTED THE PATIENT TURNED THE DOOR OFF THE OTHER DAY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108721 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1