BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4153041 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18541
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 18, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 64002, LOT# N308432, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID 3387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V129475, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. FOR THE PAST YEAR WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY GETS TO 25% OR LOWER THE PATIENT STARTED TO FEEL BAD. THE PATIENT FELT ¿RUN DOWN,¿ STAGGERED, AND HIS BALANCE WAS NOT AS GOOD. HE WANTED TO KNOW WHY HE WOULD FEEL THIS WAY WHEN THERE WAS STILL CHARGE IN THE INS BATTERY. THE PATIENT MENTIONED THAT HIS SPEECH WAS STILL SLURRED, BUT THAT WAS SOMETHING HE HAD TO TRADE OFF FOR MOBILITY. THE DOCTOR HAD TRIED TO CORRECT THIS WITH PROGRAMMING, BUT NOTHING HAD WORKED FOR HIS SPEECH. THE PATIENT WAS ALSO WORRIED THAT HE HAD FRACTURED A LEAD IN HIS NECK AGAIN. A CT SCAN WAS DONE OF HIS INS AND LEADS, BUT THE RESULT WAS NOT REPORTED. THERE WAS NO CONFIRMATION ON THE LEAD FRACTURE OR ANY FURTHER INTERVENTIONS, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631704 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1