BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2497386 · Received March 20, 2012

    Report

    Report Number
    3004209178-2012-01712
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Report Date
    February 24, 2012
    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
    CO, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    RECHARGER MODEL 37651 SERIAL# (B)(4); EXTENSION MODEL 748251 SERIAL# (B)(4) IMPLANTED (B)(6) 2007 EXPLANTED UNK; LEAD MODEL 3387S-40 LOT# V014033 IMPLANTED (B)(6) 2007 EXPLANTED UNK; LEAD MODEL 3387S-40 LOT# V014246 IMPLANTED (B)(6) 2007 EXPLANTED UNK; ADAPTOR MODEL 64002 LOT# N250517 IMPLANTED (B)(6) 2010 EXPLANTED UNK; EXTENSION MODEL 748251 SERIAL# (B)(4) IMPLANTED 3/1/2007 EXPLANTED UNK; PROGRAMMER MODEL 37642 SERIAL# (B)(4).

    Description of Event or Problem · 1

    A POWER-ON-RESET (POR) CONDITION WAS REPORTED. STIMULATION COULD NOT BE ADJUSTED AND THE PATIENT PROGRAMMER DISPLAYED A "CALL YOUR DOCTOR" ICON. THE PATIENT'S CAREGIVER WAS INSTRUCTED ON HOW TO CLEAR THE POR CONDITION. THE PATIENT PROGRAMMER INDICATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS POWERED OFF. THE INS WAS TURNED BACK ON AND THE PATIENT'S CAREGIVER WAS GOING TO MONITOR THE PATIENT'S SYMPTOMS AND INCREASE STIMULATION IF NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1