BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3250368 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12361
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37612 ,SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3387-40, LOT# L75840, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V530092, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N251196, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PAIN AT THE INCISION SITES. PATIENT HAD 5 SURGICAL INCISIONS FROM REPLACEMENT OF THE DEVICES. NEW DEVICES WERE PLACED IN THE CHEST AREA FOR RECHARGING PURPOSES. WHEN THE PATIENT SHOWERED IT WAS PAINFUL WHERE WATER HIT THE INCISIONS. PATIENT HOPED THE BANDAGES WOULD COME OFF THE DAY OF THIS REPORT. SYMPTOMS OCCURRED FOLLOWING A REPLACEMENT. IT WAS NOTED THAT THE PATIENT¿S DEVICES WERE REPLACED ON (B)(6) 2013. PATIENT WENT FROM PRIMARY CELLS TO RECHARGEABLE DEVICES. IT WAS NOTED THAT PATIENT¿S LEFT IMPLANTABLE NEUROSTIMULATOR (INS) WENT FROM 75% TO 100% IN TWO HOURS BUT THE RIGHT SIDE INS DID NOT GO FOR 75% TO 100% AFTER TWO HOURS. LEFT SIDE WAS GETTING 2-4 COUPLING BOXES AND RIGHT SIDE WAS GETTING 4 COUPLING BOXES. PATIENT SAW A SCREEN WITH A LOOP COMING OUT OF ONE SIDE AND GOING TO THE TOP OF THE OTHER SIDE. RIGHT SIDE INS HAD HIGHER SETTINGS. PATIENT STATED ¿THEY ARE SURE THERE WAS PROBABLY SWELLING.¿ IT WAS NOTED THAT SOMETIMES WHEN THE PATIENT WAS CHARGING ONE INS THEY HAD FELT ¿CURRENT PULSING THROUGH ON THE OTHER DEVICE.¿ IT WAS NOT STRONG ENOUGH TO CALL IT SHOCK. DEVICES WERE ABOVE BREASTS AND BELOW COLLAR BONE. IT WAS NOTED THAT THE PATIENT REALLY NOTICED IT WHEN THEY WERE CHARGING THE RIGHT SIDE. PATIENT WAS ALSO FEELING SURGES OF CURRENT EVEN WHEN THEY WERE NOT CHARGING. PATIENT FELT THE SURGING IN THEIR JAW ON BOTH SIDES OF THEIR MOUTH AND INTO THE CHEST. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FEELING AN ELECTRIC CURRENT THROUGHOUT THEIR BODY WHICH THEY DESCRIBED AS A JOLT. IT WAS NOTED THAT THIS HAD STARTED AFTER GETTING RECHARGEABLE DEVICES ABOUT A WEEK PRIOR TO THIS REPORT. PATIENT GETS THIS FEELING THROUGHOUT THE DAY WHEN NOT RECHARGING BUT WHILE RECHARGING IT WAS MORE PRONOUNCED. THEY WERE NOT GETTING THIS WHEN USING THE PATIENT PROGRAMMER. RECHARGING DEVICE WAS TAKING A FEW HOURS EACH TIME. RECHARGEABLE DEVICES HAD BEEN PLACED 8 INCHES AWAY FROM EACH OTHER. IT WAS NOTED THAT THIS WAS THE ONLY DIFFERENCE IN SYMPTOMS CONTROL THAT THE PATIENT HAD NOTICED SINCE REPLACEMENT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER REPORT# 3004209178-2013-12360.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350101 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR