BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2703126 · Received August 16, 2012

    Report

    Report Number
    3004209178-2012-06991
    Event Type
    Injury
    Date Received
    August 16, 2012
    Report Date
    July 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD, MODEL 3387S-40, LOT# V060436, IMPLANTED: 2008 (B)(6), EXPLANTED: NA; LEAD MODEL 3387S-40, LOT# V060436, IMPLANTED: 2008 (B)(6), EXPLANTED: NA; EXTENSION, MODEL 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: NA; EXTENSION MODEL 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: NA; PROGRAMMER, MODEL 37642, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NEW BATTERY IMPLANTED DUE TO NORMAL BATTERY DEPLETION. WHEN HE CAME OUT OF RECOVERY THE HCPS THOUGHT HE WAS HAVING SEIZURE AS HE WAS HAVING UNCONTROLLABLE THRASHING BACK AND FORTH. THE HCPS TRIED TO TURN THE DEVICE DOWN LOWER, BUT THEY COULD NOT GET IT LOW ENOUGH AND INSTEAD TURNED IT OFF. THE PATIENT STATED THAT THIS HAD LEFT HIM IN A STATE LIKE A VEGETABLE. THE PATIENT WAS CONCERNED THAT THE NEW DEVICE HAS MORE CURRENT BECAUSE HE WAS TOLD THIS BY THE IMPLANTING SURGEON. THE PATIENT STATED THAT HIS FIRST DEVICE WORKED GREAT, HE HAD NO TREMOR, AND WAS 90% BETTER. FOLLOWING THE REPLACEMENT THE PATIENT COULD ONLY SHUFFLE WITH SMALL BABY STEPS AND HIS VOICE HAD GONE SOFT. IT WAS REPORTED THAT THESE SYMPTOMS WERE NEW. THE PATIENT STATED THAT HE HAD GONE FROM HEALTHY TO A BASKET CASE. THE PATIENT HAD AN APPOINTMENT TO SEE HIS NEUROLOGIST TO HAVE HIS DEVICE PROGRAMMED ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other