BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2986151 · Received March 1, 2013

    Report

    Report Number
    3004209178-2013-03220
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    February 8, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V031488, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. HOSPITALIZATION WAS REQUIRED DUE TO THE EVENT, BUT THE PATIENT RECOVERED WITHOUT SEQUELA. ONE DAY LATER, IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT THE PATIENT COULD HARDLY WALK WHILE THE DEVICE WAS STILL IMPLANTED. THE PATIENT WAS ABLE TO WALK AFTER THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATORS (INSS) HAD BEEN REMOVED BECAUSE IT WAS REJECTED FROM HIS BODY. IT WAS STATED THAT THE DEVICE HAD COME THROUGH PATIENT'S SKIN. FOUR DAYS LATER IT WAS REPORTED THAT THE INS HAD BEEN REMOVED TWO MONTHS AGO BECAUSE IT WAS ERODING THROUGH THE SKIN. THE LEADS REMAINED IN THE PATIENT. THE INS WAS NOT REPLACED WITH ANOTHER ONE BECAUSE THE PATIENT WAS DOING MUCH BETTER WITHOUT THAT IMPLANT. IT WAS STATED THAT HE COULD NOW WALK BUT "HIS SPEECH WASN'T THE BEST ANYMORE AND HE HAD NO VOLUME." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89637 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R