BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2873472 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11819
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 19, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE WAS USED FOR WAS MRU. CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V132495, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V132495, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT WAS SHOWING SYMPTOMS THAT THE DEVICE WAS OFF. IT WAS NOTED THAT THE DEVICE RECHARGER AND PATIENT PROGRAMMER HAD BEEN LOST. NINE DAYS LATER, IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS TURNED OFF. THE REPORTER STATED THAT IT MOST LIKELY DIED BECAUSE THE PATIENT DID NOT CHARGE THE SYSTEM. IT WAS REPORTED THAT THE BATTERY WAS RECHARGED AND THE SYSTEM CAME BACK ON. IT WAS NOTED THAT THERE WAS NO HOSPITALIZATION AND NO INJURY TO THE PATIENT. THE REPORTER STATED THAT WHEN THE SYSTEM COMPLETELY DIED AND WAS RECHARGED AND TURNED BACK ON, IT CAUSED A SHOCKING 'WAVE' THAT THE PATIENT WAS AFRAID OF. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 00012 YR