BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3053120 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06024
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 27, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3387-40, LOT# V006127, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387-40, LOT# V006127, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE CAUSE OF THE EVENT WAS UNKNOWN BUT MAY HAVE BEEN DUE TO THE PROGRAMMER. IT WAS REPORTED THE DEVICES WERE OFF BILATERALLY AND THERE WAS NO INPUT. THE PATIENT HAD SYMPTOMS OF CONTINUOUS VIOLENT TREMORS AND WAS UNABLE TO WALK. THE HEALTHCARE PROVIDER REPORTEDLY TURNED THE DEVICE OFF AND BACK ON AND THE DEVICE RECOVERED. IT WAS STATED THE PROBLEM WAS RESOLVED. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND IT WAS REPORTED THE PATIENT RECOVERED WITHOUT SEQUELAE. IT WAS ALSO REPORTED THE PATIENT¿S TREMORS IMPROVED BUT THE PATIENT DID NOT RETURN TO THEIR BASELINE SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION WAS "TURNING OFF." THE PATIENT MET WITH THEIR HEALTHCARE PROVIDER (HCP) THE DAY PRIOR TO THE REPORT TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE PATIENT WENT HOME, THEY COULD "NOT STOP SHAKING." ON THE DAY OF THE REPORT, THE PATIENT WENT TO SEE THE HCP. THE HCP CHECKED BOTH OF THE IMPLANTS WITH THE CLINICIAN PROGRAMMER WHICH SHOWED "STIMULATION OFF" FOR BOTH DEVICES. THE HCP REPORTEDLY TURNED ON THE DEVICES AND RECHECKED AGAIN TO MAKE SURE THE "INS ON" ICON WAS PRESENT. IT WAS FURTHER NOTED THAT "NO REPROGRAMMING WAS DONE" DURING THE FIRST SESSION, THE HCP DID NOT THINK THE DEVICES WERE TURNED OFF DURING THE SESSION, AND THE PATIENT REPORTEDLY DID NOT ACCIDENTALLY TURN THE DEVICES OFF WITH THE PROGRAMMER. IT WAS NOTED THAT THE PATIENT WENT SHOPPING AFTER THE FIRST SESSION, WALKING THROUGH SECURITY GATES. SEE MANUFACTURING REPORT #3004209178-2013-06022. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156268 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1