BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5534249 · Received March 30, 2016

    Report

    Report Number
    3004209178-2016-05634
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    November 24, 2015
    Report Date
    December 27, 2016
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V012374, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. NEW INFORMATION REQUIRED THE ADDITION OF PATIENT CODES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE TURNED HIS PREVIOUS NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) OFF EVERY NIGHT TO CONSERVE BATTERY LONGEVITY. HE NOW HAD A RECHARGEABLE INS AND WANTED TO KNOW IF HE COULD LEAVE IT ON THROUGH THE NIGHT. HE WANTED TO DO THIS BECAUSE HE GETS A REALLY HARD JOLT WHEN HE TURNED THE DEVICE ON IN THE MORNING. THIS HAD OCCURRED SINCE IMPLANT. THE PATIENT ALSO MENTIONED THAT ONCE HE DID NOT CHARGE HIS BATTERY FOR FOUR DAYS AND IT TOOK EXACTLY THREE HOURS TO FULLY RECHARGE THE INS. THE PATIENT'S INDICATIONS FOR USE WERE MOVEMENT DISORDERS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT HIS LEFT HAND STARTED SHAKING, SO THE HEALTHCARE PROVIDER (HCP) ADJUSTED HIS DEVICE TO HIS CHOICE OF A, B, OR C AND THE SHOCKING STARTED. HE SAW HIS HCP ON (B)(6) 2016 AND HE ADJUSTED HIS CONTROLLER, BUT IT DID NOT HELP. HE THEN SAW THE HCP AGAIN ON (B)(6) 2016 AND HE ENDED UP TELLING THE PATIENT TO TURN THE DEVICE ON BEFORE GETTING UP, WHICH HELPED A LITTLE. THE PATIENT NOW NO LONGER TURNED HIS DEVICE ON AND OFF, HE JUST LEFT IT TURNED ON. LEAVING THE DEVICE ON SOLVED THE PROBLEM. HOWEVER, THE PATIENT DEVELOPED AN INFECTION WHICH FOLLOWED THE WIRES UP TO HIS BRAIN. HE SAW THE HCP ON (B)(6) 2016 AND THE SYSTEM WAS REMOVED TWO DAYS LATER. THE PATIENT AND CONSUMER WONDERED IF THE INFECTION AFFECTED THE WIRES LEADING TO THE SHAKING AND SHOCKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED 6-9 MONTHS BEFORE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189980 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention