BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3243052 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12180
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V100240, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V022472, IMPLANTED: 2007,(B)(6), PRODUCT TYPE LEAD PRODUCT ID NEU_WRENCH_ACC LOT# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS EVENT INVOLVED THE PATIENT'S OTHER DEVICE, AS REPORTED IN MFR. REPORT #300420917 8-2013-12179, AND DID NOT INVOLVE THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED, THE PATIENT HAD A LOSS OF THERAPY ON ONE SIDE AND SHOCKING IN THEIR CHEST AFTER THE REPLACEMENT OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE PATIENT REPORTED THIS TWO DAYS PRIOR TO REPORT AND WAS SEEN IN A CLINIC AND THEIR NEUROSURGEON SAW THE X-RAY ON THE DAY OF REPORT. IT WAS REPORTED, THE EXTENSION WAS NOT FULLY CONNECTED TO THE INS ON ONE SIDE. IT WAS STATED, THE NEUROSURGEON THOUGHT THE TORQUE WRENCH WAS NOT TIGHTENING PROPERLY SO THEY HAVE GONE BACK TO USING A HEX WRENCH AND HADN¿T HAD ANY OTHER ISSUES. IT WAS NOTED, THE TORQUE WRENCH WAS USED ON BOTH DEVICES WITH THIS PATIENT BUT ONLY ONE SIDE HAD BEEN A PROBLEM. IT WAS LATER REPORTED, THE PATIENT WAS SCHEDULED TO HAVE THE ISSUE CORRECTED ON (B)(6) 2013. IT WAS LATER REPORTED, THE PATIENT SAW THEIR PHYSICIAN THE DAY PRIOR TO REPORT AND IT WAS DETERMINED THEIR SETSCREW HAD BECOME LOOSE ON THEIR INS CONNECTION. IT WAS STATED, THE PHYSICIAN FELT THE SETSCREW HAD A MALFUNCTION. IT WAS NOTED, THE PATIENT HAD SOME DISCOMFORT BEHIND AND NEAR THEIR INS. IT WAS ALSO STATED DIAGNOSTIC EXAMINATIONS WERE PERFORMED AND IT WAS DETERMINED # 3 WAS LOOSE AND A CHEST AND SKULL X-RAY WAS DONE. IT WAS LATER REPORTED, THE TORQUE WRENCH WAS NOT APPLYING ENOUGH TORQUE TO KEEP THE EXTENSION IN THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS LATER REPORTED, THE PATIENT¿S ISSUE WOULD BE FIXED THE DAY AFTER REPORT. A DAY LATER, IT WAS REPORTED, THE PATIENT¿S BATTERY WAS REMOVED, THE SET SCREWS WERE RETIGHTENED AND IMPEDANCES MEASUREMENTS WERE TAKEN. IT WAS STATED CONTACT THREE IMPEDANCES WERE HIGH AND OUT OF RANGE. IT WAS NOTED AFTER FURTHER TESTING A PROBLEM WAS FOUND IN THE EXTENSION WIRE AND THERE WAS A VISIBLE BREAK NEAR THE PLUG. IT WAS STATED BOTH THE BATTERY AND EXTENSION WERE EXPLANTED AND A NEW EXTENSION AND BATTERY WERE IMPLANTED. IT WAS UNKNOWN WHICH OF THE PATIENT'S EXTENSIONS AND BATTERIES WERE EXPLANTED. REFERENCE RELATED MANUFACTURER REPORT # 3004209178-2013-12179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343116 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention