BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4090222 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17041
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 25, 2014
    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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V635198, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V635198, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CONCERNED THAT THE BATTERY WAS CLOSE TO NEEDING REPLACEMENT AFTER A YEAR. THE PATIENT¿S BATTERY VOLTAGE WAS AT 2.88 AND HE INQUIRED ABOUT A POSSIBLE SHORT, THUS DRAINING THE BATTERY. HE INDICATED THAT THERAPY WAS GOOD, BUT OCCASIONALLY HE HAD A SHARP PAIN ON TOP OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THIS INS WAS ALSO PROTRUDING MORE THAN THE PATIENT¿S FIRST ONE. HE ALSO HAD HEADACHES ALONG THE TRAIL OF THE LEAD WIRE. IT HAD BEEN LIKE THAT FOR A WHILE. THE PATIENT¿S DEPLETION CONCERNS WERE NOT VALIDATED EITHER WAY YET. THERE WAS NO INTERVENTION OR PATIENT OUTCOME REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE PATIENT REPORTED THAT HE STILL HAD CONCERNS WITH HIS DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568616 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1