BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3012665 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03958
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, V514982, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V514982, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FIRST PHYSICIAN THAT THE CONSUMER WAS NOT THEIR PATIENT. IT WAS FURTHER REPORTED BY THE SECOND PHYSICIAN THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PHYSICIAN WAS UNAWARE OF THE PROBLEM, AS THE PATIENT DID NOT SHOW FOR THE LAST APPOINTMENT. SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE HEALTHCARE PROVIDERS FOR ADDITIONAL INFORMATION WERE MADE, BUT NO NEW INFORMATION REGARDING THE EVENT WAS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A ONE-TIME SHOCK. SYMPTOM CONTROL DECLINED QUICKLY WITH A CHANGE IN GAIT, INCREASED TREMOR, RIGIDITY/SPASM, FREEZING AND THREE FALLS. A COMPANY REPRESENTATIVE INTERROGATED THE DEVICE, RAN IMPEDANCE TESTS (BOTH THERAPY AND FULL SYSTEM) AND CHECKED THE SYSTEM, AND NO ISSUES WERE FOUND. BATTERY LIFE WAS AT 2.92V. THE PATIENT IS SCHEDULED TO BE SEEN IN MARCH FOR MEDICATION EVALUATION/ADJUSTMENT AND REPROGRAMMING OF THE DEVICE. THE PATIENT HAS NOT BEEN SEEN/ADJUSTED FOR 6 MONTHS DUE TO A MOVE. THE PATIENT STATUS WAS NOTED TO BE ALIVE/NO INJURY/NO ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, IF OBTAINED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115603 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR