BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3975917 · Received August 4, 2014

    Report

    Report Number
    3004209178-2014-13879
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, LOT# N410747, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V053450, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V068863, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 64002, LOT # N410747, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V053450, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V068863, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WOKE UP ON THE MORNING OF THE DATE OF THIS REPORT AND FELT A PULLING FROM HER DYSTONIA ON HER RIGHT SIDE. THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE PATIENT SAW THE POOR COMMUNICATION SCREEN. IT WAS NOTED THAT THE PATIENT HAD TRIED REPLACING THE BATTERIES AND WAS STILL SEEING THE POOR COMMUNICATION SCREEN. IT WAS CONFIRMED THAT THE PATIENT PROGRAMMER WAS NOT BEING HELD OVER THE IMPLANTABLE NEUROSTIMULATOR (INS) WHEN THE PATIENT WAS CHECKING THE DEVICE. PATIENT PLACED THE PROGRAMMER OVER THE IMPLANT AND PRESSED THE CHECK BUTTON AND WAS SEEING ON AND OK. THERE WAS RETURN OF DYSTONIC SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR AND THEIR CONCERNS WERE RESOLVED. PATIENT WAS WORKING WITH THEIR DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453993 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR