BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2565648 · Received May 9, 2012

    Report

    Report Number
    3007566237-2012-01010
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    March 2, 2012
    Report Date
    April 30, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 64002 SERIAL# UNKNOWN PRODUCT TYPE ADAPTER; PRODUCT ID 3387 SERIAL# UNKNOWN PRODUCT TYPE LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: CHELVARAJA, R., LUMSDEN, D., KAMINSKA, M., SAMUEL, M., HULSE, N., SELWAY, R., LIN, J-P., ASHKAN, K. SHIELDED BATTERY SYNDROME: A NEW HARDWARE COMPLICATION OF DEEP BRAIN STIMULATION. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2012;90:113-117. SUMMARY: DEEP BRAIN STIMULATION HARDWARE IS CONSTANTLY ADVANCING. THE LAST FEW YEARS HAVE SEEN THE INTRODUCTION OF RECHARGEABLE CELL TECHNOLOGY INTO THE IMPLANTED PULSE GENERATOR DESIGN, ALLOWING FOR LONGER BATTERY LIFE AND FEWER REPLACEMENT OPERATIONS. THE MEDTRONIC SYSTEM REQUIRES AN ADDITIONAL POCKET ADAPTOR WHEN REVISING A NON-RECHARGEABLE BATTERY SUCH AS THEIR KINETRA TO THEIR RECHARGEABLE ACTIVA RC. THIS ADDITIONAL HARDWARE ITEM CAN, IF IT MIGRATES SUPERFICIALLY, BECOME AN IMPEDIMENT TO THE RECHARGING OF THE BATTERY AND NEGATE THE INTENDED TECHNOLOGICAL ADVANCE. AIM WAS TO REPORT THE EMERGENCE OF THE 'SHIELDED BATTERY SYNDROME', WHICH HAS NOT BEEN PREVIOUSLY DESCRIBED. WE REVIEWED OUR DEEP BRAIN STIMULATION DATABASE TO IDENTIFY CASES OF RECHARGING DIFFICULTIES REPORTED BY PATIENTS WITH ACTIVA RC IMPLANTED PULSE GENERATORS. TWO CASES OF SHIELDED BATTERY SYNDROME WERE IDENTIFIED. THE FIRST REQUIRED SURGERY TO REPOSITION THE ADAPTOR TO THE DEEP ASPECT OF THE SUBCUTANEOUS POCKET. IN THE SECOND CASE, IT WAS POSSIBLE TO PERFORM EXTERNAL MANUAL MANIPULATION TO RESTORE THE ADAPTOR TO ITS ORIGINAL POSITION DEEP TO THE BATTERY. WE DESCRIBE STRATEGIES TO MINIMISE THE OCCURRENCE OF THE SHIELDED BATTERY SYNDROME AND ADVISE VIGILANCE IN ALL PATIENTS WHO EXPERIENCE DIFFICULTY WITH RECHARGING AFTER REPLACEMENT SURGERY OF THIS TYPE FOR THE IMPLANTED PULSE GENERATOR. REPORTED EVENT: FOUR MONTHS AFTER IMPLANT OF THE ACTIVA RC THE PATIENT'S FAMILY REPORTED DIFFICULTIES IN RECHARGING THE IPG. WHEN THEY ATTEMPTED TO USE THE RECHARGER PLACED PERCUTANEOUSLY OVER THE IPG, NONE OF THE MARKER SQUARES AT THE BASE OF THE RECHARGER'S SCREEN TURNED OPAQUE. PALPATION AND X-RAYS OF THE CHEST WALL DEMONSTRATED THAT THE ADAPTOR HAD MIGRATED TO LIE SUPERFICIAL TO THE IPG. AN X-RAY CONFIRMED THAT THE ADAPTOR WAS EXTERNALLY MANIPULATED BACK TO THE DEEP ASPECT OF THE IPG. FOLLOWING THIS, THE ABILITY TO RECHARGE THE BATTERY WAS RESTORED WITHOUT NEED FOR FURTHER INTERVENTION TO THE CURRENT TIME (NOW 15 MONTHS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR