BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5152773 · Received October 15, 2015

    Report

    Report Number
    3004209178-2015-20708
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    September 17, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3387S-40, LOT# V020895, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V020895, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37761; PRODUCT TYPE RECHARGER

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT WHEN THEY RECHARGED THE IMPLANTABLE NEUROSTIMULATOR (INS), THE BATTERY WAS DECREASING AND NOT INCREASING. THE PATIENT ALWAYS HAD ALL EIGHT COUPLING BOXES WHEN THEY RECHARGED THE INS. THE PATIENT HATED THE RECHARGER AND THEY HAD BEEN HAVING A LOT OF TROUBLE WITH THE RECHARGER. THE PATIENT ALSO MENTIONED THE DESKTOP CHARGER GOT WARM. THE PATIENT'S INDICATION FOR USE IS EPILEPSY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682595 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR