BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4847869 · Received June 16, 2015

    Report

    Report Number
    3004209178-2015-11667
    Event Type
    Injury
    Date Received
    June 16, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN, LOT# A01411A004; PRODUCT TYPE UNKNOWN PRODUCT ID 3093-33, LOT# VA0SYHL, IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-33, LOT# VA0QQ37, IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID NEU_RECHARGER_ACC, SERIAL# UNKNOWN; PRODUCT TYPE RECHARGER. (B)(4). DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS P970004.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON 2015 (B)(6) THAT THE PATIENT NOTED THERE WAS AN ISSUE REGARDING RECHARGER / RECHARGING. A COUPLING PROBLEM WAS REPORTED. THE PATIENT WAS NOT ABLE TO GET MORE THAN 2 BARS SHADED SINCE AFTER THE FIRST TIME SHE RECHARGED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN HIP AND THE PATIENT NEVER RECEIVED A BELT. IT WAS REVIEWED HOW TO ADJUST ANTENNA DIAL. REVIEWED HOW TO REPOSITION ANTENNA AND PRESS START CHARGE BUTTON. RECOMMENDED USING ANTENNA LOCATE FEATURE. THIS DID NOT RESULT IN ANY IMPROVEMENT. RECOMMENDED PALPATING INS POCKET TO ASSESS DEPTH AND POSITION OF INS. THE PATIENT DID NOT FEEL LIKE THERE WAS ANY SWELLING OR HARDLY ANY MOVEMENT AT INS POCKET. RECHARGING WAIST BELT - PATIENT NEVER RECEIVED AND INS IS IMPLANTED IN HIP AREA. THE PATIENT NEVER RECEIVED A BELT. NO ITEM RETURNED, C500. IT WAS LATER REPORTED ON (B)(6) 2015 THAT THE CALL WAS ABOUT RECHARGER / RECHARGING. A COUPLING PROBLEM WAS REPORTED. RECOMMENDED USING ANTENNA LOCATE FEATURE. THE CALLER WAS ABLE TO GET A VALUE OF 60 AND HER RANGE WAS 44-60. RECOMMENDED PALPATING IMPLANTABLE NEUROSTIMULATOR (INS) POCKET TO ASSESS DEPTH AND POSITION OF INS. THE CALLER SAID THAT THE INS WAS SUPERFICIAL, BUT WOBBLED IN THE POCKET. CALLER REPORTED CHARGING MORE THAN EXPECTED. IT WAS REVIEWED THAT CHARGING WILL TAKE LONGER WITH LOWER COUPLING AND THAT 2-5 HOURS PER QUARTILE WITH 2 COUPLING BOXES IS NOT UNREALISTIC. EVENT ONE: ONLY TWO COUPLING BOXES EVENT DATE: (B)(6) 2015 EVENT TWO: TAKING LONGER TO CHARGE EVENT DATE: (B)(6) 2015 EVENT THREE: INS SEEMED WOBBLY IN POCKET EVENT DATE: (B)(6) 2015 EVENT FOUR: INS OFF (LIKELY DUE TO LOW INS BATTERY CHARGE LEVEL) EVENT DATE: (B)(6) 2015 ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE NOTED THAT THE PATIENT WAS IN CYCLING MODE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. REGARDING IF IT WAS DEVICE RELATED, IT WAS NOTED AS N/A. IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING THERAPY AND UNABLE TO CHARGE IN A TIMELY MANNER. A DEVICE FLIP WAS NOT CONFIRMED. X-RAY SHOWED NO FLIP. SYMPTOMS RETURNING WAS NOTED. REGARDING ANY TROUBLESHOOTING, INTERVENTION OR OTHER ACTIONS TAKEN TO RESOLVE THE EVENT, IT WAS NOTED: TECHNICAL SERVICES CALLED WHILE WITH PATIENT. TROUBLESHOOTING OCCURRED. THEY WERE ONLY ABLE TO GET TWO BARS WHILE TRYING TO CHARGE. PER TECH SERVICES, IT WOULD TAKE 13+ HOURS AT THAT RATE TO CHARGE. PATIENT REPORTS CHARGING EVERY WEEK WITH NO IMPROVEMENT IN BATTERY LIFE NOTED. (B)(6) 2015. DOCTOR ORDERED X-RAY. THE PATIENT WAS NOT RECEIVING THERAPY AND WAS SCHEDULED FOR A REPLACEMENT OF IPG ON 6/9/15. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT NOTED THAT THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE. APPOINTMENT DATES WERE NOTED AS (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390712 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention