BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2564407 · Received May 8, 2012

    Report

    Report Number
    3007566237-2012-01002
    Event Type
    Injury
    Date Received
    May 8, 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 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED:; PRODUCT TYP ADAPTER PRODUCT ID 3387 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED:; PRODUCT TYP LEAD. (B)(4). 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: CASE 1: EIGHT MONTHS FOLLOWING IMPLANTATION OF THE ACTIVA RC, THE PATIENT BEGAN TO EXPERIENCE DIFFICULTIES WITH RECHARGING. WHEN SHE 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, IMPLYING THAT COUPLING WAS NOT AT ALL ACHIEVED. THIS WAS IN CONTRAST TO THE PREVIOUS OCCASIONS WHEN CHARGING HAD OCCURRED CORRECTLY, WITH ALL SQUARES TURNING OPAQUE TO INDICATE SUCCESSFUL COUPLING. PALPATION AND X-RAYS REVEALED THAT THE ADAPTOR WAS NOW LYING SUPERFICIAL TO THE IPG EXTERNAL MANUAL MANIPULATION WAS PERFORMED, WHICH RESTORED THE ADAPTOR TO THE DEEP ASPECT OF THE POCKET BENEATH THE IPG. THE ABILITY TO RECHARGE THE BATTERY WAS RESTORED. FIVE MONTHS LATER, THE SAME DIFFICULTY AROSE COMPOUNDED WITH SYMPTOMATIC WORSENING IN THE DYSTONIA. PERCUTANEOUS REPOSITIONING OF THE ADAPTOR WAS NOT POSSIBLE, AND SURGICAL EXPLORATION OF THE SUBCLAVICULAR POCKET WAS THEREFORE UNDERTAKEN. IT WAS FOUND THAT THE ADAPTOR WAS LYING SUPERFICIAL TO THE ACTIVA RC. THE ADAPTOR WAS; THEREFORE, SURGICALLY ANCHORED TO THE DEEP ASPECT OF THE POCKET DEEP TO THE IPG. THE BATTERY POCKET WAS ALSO REDUCED IN SIZE WITH SUTURES TO MINIMIZE FURTHER MIGRATION. THE PATIENT'S CHARGING TIMES AND CLINICAL EFFICACY WERE RESTORED WITHOUT RECURRENCE OF THIS PROBLEM TO THE PRESENT TIME (NOW 9 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 00019 YR Required Intervention PRODUCT ID 64002 LOT# SERIAL# UNKNOWN IMPLANTED: