BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3243024 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12179
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# V100240, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V022472, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID NEU_WRENCH_ACC, LOT# UNKNOWN, PRODUCT TYPE ACCESSORY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 37602 (LOT # NLA706551H) SHOWED INS FUNCTIONALLY OKAY, INSIGNIFICANT ANOMALIES. NO SIGNIFICANT ANOMALY. FINAL ANALYSIS OF EXTENSION MODEL 7482A51 (LOT # NHU147947V) SHOWED EXTENSION BODY CONDUCTOR BROKEN, COILED WIRE IN BODY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 BATTERIES AND EXTENSIONS WERE EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE CHANGE OUT IT WAS SUSPECTED OR CONFIRMED THAT THE CONTACT WAS NOT FULLY TIGHTENED WITH THE TORQUE WRENCH, RESULTING IN HIGH IMPEDANCES "AND WHEN THEY GO BACK INTO A DISCONNECT." IT WAS REPORTED THAT THE CASE PRESENTED WITH LOSS OF THERAPEUTIC EFFECT AND HIGH IMPEDANCES ON A CONTACT. IT WAS NOTED THAT WITH THE OLD NON-TORQUE SCREWDRIVER THE DOCTOR NEVER HAD ISSUES AND FELT THIS WAS RELATED TO THE CURRENT TORQUE WRENCH. IT WAS REPORTED THAT THE DOCTOR WAS NOT DOING ANYTHING "DIFFERENTLY THAT BEFORE" IN HIS CHANGE OUT PRACTICE AND THAT IS WHY HE FELT IT WAS A TORQUE WRENCH ISSUE. IT WAS NOTED THAT THE DOCTOR HAD DONE A LOT OF CASES. SEE ALSO MFR. REPORT #303004209178-2013-03269 WHERE THE SAME DOCTOR HAD SIMILAR ISSUES WITH A DIFFERENT PATIENT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT DID NOT HAVE AN ISSUE WITH THE SET SCREWS AS ORIGINALLY THOUGHT AND THERE WAS A BREAK IN THE EXTENSION WIRE. IT WAS LATER REPORTED THAT THERE WAS NORMAL BATTERY DEPLETION AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344338 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