BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3980022 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13954
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT # VA09EVPV02, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708640, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # VA09EVPV02, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE RETURN OF SYMPTOMS JUST THE ¿BALL ON TOP OF THE DEVICE.¿ THE SYMPTOMS WERE REPORTED AS A SUDDEN ONSET AT THE IMPLANTABLE NEUROSTIMULATOR (INS) LOCATION. IT WAS NOTED THAT THE PATIENTS LEFT BATTERY WAS AFFECTED AND COULD VISUALLY SEE THE BUMP. IT WAS NOTED THAT THE NEUROLOGIST CHECKED THE DEVICE WITH THE CLINICIAN PROGRAMMER AND X-RAYS BECAUSE HE WAS INITIALLY CONCERNED THAT THE PATIENT PULLED THE CONNECTOR AND WIRES OUT OF THE BATTERY INSIDE, BUT IT WAS VERIFIED THAT THE DEVICE AND THERAPY WERE WORKING AS INTENDED. TWO DAYS PRIOR TO THE DAY OF THE REPORT, THE PATIENT BUMPED ON TOP OF A FLAT ROUND DEVICE, AND IT WAS REPORTED THERE WAS A BUMP ON TOP OF THE IMPLANT. AN X-RAY WAS COMPLETED TODAY AND IT WAS REPORTED THAT THE WIRES WERE ¿LIKE A HAIRBALL¿ ON TOP OF THE DEVICE, AND WAS UNSURE IF IT WAS ONE OR TWO WIRES. IT WAS NOTED THAT IT WAS OKAY BECAUSE THE DEVICE WAS WORKING, BUT THE PATIENT WAS CONCERNED SINCE IT WASN¿T THAT WAY BEFORE AND NOW ¿IT IS THE WAY.¿ IT WAS CONFIRMED THAT THE BUMP WAS FIRST NOTICED TWO DAYS AGO. THE PATIENT PULLED ON IT THAT DAY AND HASN¿T BEFORE. IT WAS REPORTED THAT THE DEVICE WAS NOT HURTING THE PATIENT. IT WAS NOTED THAT THIS WAS THE LEFT DEVICE. X-RAY CONFIRMED THAT IT WAS THE WIRES AND NOT A HEMATOMA OR SEROMA. IT WAS REPORTED THAT THERE WASN¿T ANY TWISTING AND IT WAS TIGHT AND COULDN¿T BE MOVED AROUND. IT WAS REPORTED THAT THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. THERE WAS A CONCERN ABOUT A KNOT AT THE EDGE OF THE LEFT INS. THE GENERATOR WAS INTERROGATED; SETTINGS AND IMPEDANCES WERE WITHIN NORMAL EXPECTATIONS. THE LEAD HAD IMPROVED FROM THEIR PERVIOUS VISIT. GAIT IMPROVED AND WAS SMOOTH. X-RAYS OF THE LEFT INS PLACEMENTS AND EXTENSIONS SHOWED THE LEAD WIRE WAS PARTIALLY IN A BALL BUT STILL CONNECTED TO THE INS. IT WAS REPORTED THAT THE PATIENT LIKED TO PLAY WITH THE INS AND TWIDDLED THE EXTENSION ON THE LEFT CHEST INTO A KNOT. THERE WAS NO CHANGE IN FUNCTION, PATIENT WAS ASYMPTOMATIC AND OVERALL FUNCTION GREATLY IMPROVED. NO FURTHER INTERVENTION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458104 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR