BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 1963492 · Received December 20, 2010

    Report

    Report Number
    3007566237-2010-10604
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO FROM HCP THAT POST-OPERATIVELY WHEN DEVICE WAS INTERROGATED, BOTH TIMES WERE HIGH IMPEDANCES >4000. THIS WAS NOTED ON ALL COMBOS WITH #8, C-8=4258, 8-9=3483, 8-10=4677 AND 8-10=4677, ALL OTHER COMBOS WERE NORMAL. IMPEDANCES WERE NOT CHECKED INTRA-OPERATIVELY BECAUSE PT HAD NORMAL IMPEDANCES AND GOOD THERAPY GOING INTO THE PROCEDURE AND IT WAS JUST AN INS CHANGE OUT. PATIENT'S PREVIOUS THERAPY WAS PROGRAMMED USING THE #8 CONTACT, C+8-, 4,9V, 180US 60HZ (DYSTONIA). HCP IS UNSURE IF OTHER PROGRAMMING WOULD BE EFFECTIVE FOR THE PT IF #8 IS NOT AVAILABLE. ADDITIONAL INFO REPORTS PT AND HIS WIFE HAD SOME RECHARGING ISSUES, BUT THIS WAS FELT TO BE CAUSED BY INCISIONAL SWELLING AND THE BANDAGES PRESENT. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFERENCE MFR REPORT # 3004209178201010605.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MEDTRONIC NEUROMODULATION 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR IMPLANTABLE NEURO STIMULATOR: MODEL 37612| UNK CONVERSION TYPE: MODEL 3550-09, LOT# N170731| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NFD111031H| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 240620002| UNK CONVERSION TYPE: MODEL 3550-09, LOT# N166552| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ADAPTER: MODEL 64001, LOT# N259554| EXPLANTED:| LOT# NKG701456H| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU060805V| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU104954V| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0428156V| EXPLANTED:| IMPLANTED:| LOT# NFD111032H| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| ACCESSORY: MODEL 37651, LOT# NKA146010N| LEAD: MODEL 3387, LOT# J0428156V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0437506V| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ108241N| IMPLANTED:| EXPLANTED: