BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1861165 · Received October 4, 2010

    Report

    Report Number
    3004209178-2010-07586
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A SHOCKING OR JOLTING SENSATION AFTER THE PT WAS ACCIDENTLY SHOCKED BY A LIGHT SOCKET THE PREVIOUS NIGHT. THE PT HAD INCREASED BLADDER PAIN, DECREASED URINARY FREQUENCY, AND "BURNED FINGERS." ALSO, THE PT STATED THERE WAS "EROSION," AND THAT THE PT'S BODY "REJECTED" THE RIGHT LEAD. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. REFER TO MFR REPORT #3004209178201007583.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR PROGRAMMER: MODEL 3037, LOT# NJD103399N| PROGRAMMER: MODEL 3037, LOT# NJD103400N| LEAD: MODEL 3889, LOT# V422402| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NJY137266H| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,