BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2884150 · Received December 21, 2012

    Report

    Report Number
    3007566237-2012-03103
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    August 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD RECEIVED TWO IMPLANTS IN (B)(6) 2012 AND THAT MANUFACTURER'S DATABASE HAD NOT BEEN UPDATED YET. WHEN THE PATIENT WAS CHECKED ON (B)(6), HER IMPEDANCES WERE NORMAL AND HER THERAPY WAS GOOD. THE PATIENT HAD IMPLANTS FOR MAJOR DEPRESSIVE DISORDER. ON THE DAY OF THE REPORT, THE PATIENT CAME IN FOR 3 MONTH FOLLOW UP. IT WAS NOTICED THAT THE RIGHT LEAD/SYSTEM HAD >40000 OHMS FOR IMPEDANCES ON ALL ELECTRODE PAIRS. THE LEFT SIDE WAS REPORTED TO BE FINE/NORMAL. NO FALLS/TRAUMA WERE ASSOCIATED WITH HIGH IMPEDANCES. IT WAS INDICATED THAT THE PATIENT HAD ADDITIONAL PSYCHOSOCIAL STRESSES, BUT IT WAS UNKNOWN IF MAJOR THERAPY CHANGE WAS NEEDED AT THIS TIME. LEAD CONFIGURATION WAS CONFIRMED TO BE PROPER. LEFT LEAD SETUP WAS 1-, 2+. RIGHT LEAD SETUP WAS 0+, 1-. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFER TO MANUFACTURER REPORT #3007566237-2012-03102. TWO DEVICES WERE IMPLANTED AND IT WAS UNCLEAR WHICH DEVICE THE REPORTS PERTAINED TO.

    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