BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3233740 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11959
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    September 16, 2012
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS MRU. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V388241, IMPLANTED: (B)(6) 2010: PRODUCT TYPE LEAD; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010: PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 37651, SERIAL# (B)94): PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN IMPLANTABLE NEUROSTIMULATOR (INS) RECHARGING ISSUE. IT WAS NOTED ¿THERE WAS A PROBLEM. IT WAS NOT CHARGING UP.¿ CONNECTION WAS NOT ESTABLISHED AND THE PATIENT WAS UNABLE TO CHARGE AT ALL. THE PATIENT HAD NOT CHARGED IN "AT LEAST A MONTH." OVERDISCHARGE WAS SUSPECTED AND IT WAS ALSO REPORTED THAT ¿THE BATTERY JUST WENT DEAD.¿ NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD NEW ¿WIRES¿ IMPLANTED A MONTH PRIOR. THE PATIENT WAS STILL HAVING TROUBLE CHARGING AND DID NOT GET ALL OF THE COUPLING BARS. THE CHARGE WAS NOTED TO BE AT 50%. IT WAS THOUGHT THAT THE RECHARGER WAS CHARGING THE IMPLANTABLE NEUROSTIMULATOR BECAUSE THE RECHARGER WAS CLICKING. IT WAS ALSO REPORTED THAT THE PATIENT WAS CURRENTLY CHARGING AND WAS GETTING ALL OF THE COUPLING BARS ON THE RECHARGER. THE PATIENT HAD BEEN CONFUSING THE COUPLING BARS WITH THE STIMULATOR¿S CHARGE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336197 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR