BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2227075 · Received August 22, 2011

    Report

    Report Number
    3004209178-2011-06652
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE MEASURED AT 3 VOLTS. THE IMPEDANCES WERE HIGH ON BOTH SIDES: C0 24766, C1 1359, C2 16632, C3 23827, 01 25366, 02 22789, 03 29678, 12 16721, 13 23471, 23 11020, C8 18964, C9 1297, C10 16372, C11 11380, 89 20725, 810 27353, 811 26885, 910 16544, 911 11633, 1011 15110. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED LOSS OF THERAPY AND RETURN OF SYMPTOMS. X-RAYS WERE TAKEN AND THE EXTENSION APPEARED TO BE TWISTED NEAR THE IMPLANTABLE NEUROSTIMULATOR. EXTENSION REVISION WAS PERFORMED (B)(6) 2011. IMPEDANCE ISSUE WAS REMOVED. PT OUTCOME WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ107030N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN012630V| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V553427| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN012625V