BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3071436 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06682
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS MFR.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3391S-40 LOT# V556815, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3391S-40 LOT# V556815, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37092 LOT# 375650002, PRODUCT TYPE ACCESSORY PRODUCT ID 37651 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. F(B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS CHARGING THE DEVICE MORE THAN EXPECTED. THE PATIENT NEEDED TO CHARGE OVER SIX HOURS A DAY. IT WAS NOTED THAT THE PATIENT PLANNED TO FOLLOW UP WITH HER MANAGING HEALTH CARE PROFESSIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD TURNED OFF AND SHE WAS UNABLE TO TURN IT BACK ON. THE PATIENT HAD CHARGED IT TO 80% THE NIGHT PRIOR. THE NEXT MORNING, THE DAY OF THE REPORT, THE PATIENT'S THERAPY WAS OFF AND THE BATTERY WAS "COMPLETELY GONE." THE PATIENT WAS TOLD TO RECHARGE AS MUCH AS SHE CAN AND THEN ATTEMPT TO TURN ON THE STIMULATOR AGAIN. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEEDED TO CHARGE 6-7 HOURS A DAY AND IT WAS NOT GETTING UP TO 100%. THE PATIENT'S SETTING WERE:PULSE WIDTH 120, 7.5V, AND A RATE OF 210. IT WAS NOTED THAT OVERNIGHT THE BATTERY GOES DOWN TO 50%. IT WAS REPORTED THAT WHILE CHARGING, THE CHARGER "GOES OFF NOW AND THEN" AND THE PATIENT HAS TO RESTART IT. IT WAS NOTED THAT THE PATIENT WAS GOING TO MEET WITH A COMPANY REPRESENTATIVE AT HER DOCTOR'S OFFICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD ONLY BEEN HAVING ISSUES RECHARGING IN THE LAST COUPLE OF WEEKS. IT WAS NOTED THAT THE PATIENT HAD NO TRAUMA OR FALLS; HOWEVER, A HEALTH CARE PROVIDER THOUGHT THAT THE PATIENT DID FALL AT ONE POINT WHILE RUNNING. IT WAS NOTED THAT THE PATIENT REPORTED GETTING 8 BARS WHILE RECHARGING AND THE RECHARGING DETAILS FROM THE CLINICIAN PROGRAMMER INDICATED THIS AS WELL. WHEN A REPORT WAS RUN FROM THE RECHARGER ITSELF, THE REPORT INDICATED THAT THE PATIENT WAS ONLY GETTING 5-6 BARS IN SOME OF HER RECHARGING SESSIONS RATHER THAN THE 8 BARS. DESPITE THIS, IT TOOK THE PATIENT 2-3 HOURS FOR THE IMPLANTABLE NEUROSTIMULATOR BATTERY LEVEL TO INCREASE 25%. THE PATIENT WAS GOING TO TRY TO USE ADHESIVE DISCS TO HELP WITH THE RECHARGING. IT WAS NOTED THAT THE PATIENT WAS GETTING ADEQUATE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE STICKERS WERE HELPING WITH THE RECHARGING AS THE TIME TO CHARGE WAS DOWN TO FOUR HOURS A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173177 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR