BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2991120 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03375
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 13, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V004231,IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# V003448, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "WEAKNESS." IT WAS FURTHER REPORTED THAT THE PATIENT HAD UNDERGONE "SPEECH THERAPY" FOR THREE WEEKS PRIOR TO REPORT. THE SPEECH THERAPY WAS STATED TO INVOLVE USE OF "AN ELECTRIC STIMULATOR" TO THE PATIENT'S THROAT. IT WAS REPORTED THAT THE PATIENT "FELT SEVERELY WEAK" DURING THE THERAPY. IT WAS ADDITIONALLY REPORTED THAT THE WEAKNESS WAS "EXACERBATED DURING THERAPY AND THEN LINGERED." IT WAS FURTHER NOTED THAT THE PATIENT FELT "TERRIBLE" AT THE TIME OF REPORT. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS NOTED TO HAVE REMAINED ON AFTER THE THERAPIES. IT WAS ADDITIONALLY NOTED THAT THE PATIENT NORMALLY RESPONDED "QUICKLY" TO HER DEVICE BEING TURNED ON OR OFF. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE REFERENCE MFR REPORT # 3004209178-2013-03374 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THE HCP HAD THE PATIENT'S HUSBAND VERIFY THAT THE DBS STIMULATORS DID NOT TURN OFF WITH THE USE OF THE SPEECH THERAPY STIMULATOR. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO PATIENT INJURY. IT WAS NOTED THAT THE HCP NEVER HEARD BACK FROM THE PATIENT AS TO WHETHER THE STIMULATORS WERE TURNED OFF BY THE SPEECH THERAPY STIMULATOR.

    Description of Event or Problem · 1

    THIS WAS A BILATERAL SYSTEM. REFERENCE MFR 3004209178-2013-03374.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95070 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1