BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1993768 · Received January 13, 2011

    Report

    Report Number
    3007566237-2011-00363
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS REPROGRAMMED AFTER DEVICE REPLACEMENT (AFTER CHRISTMAS) AND WAS STILL HAVING ISSUES, INCLUDING BLOOD AND SCABS IN THE URINE. IT WAS REPORTED THAT THE PT FELT "LIKE THE JUICES JUMP ALL OVER FROM TESTICLES TO BLADDER TO URETHRA." OTHER SYMPTOMS INCLUDED "FIRE-LIKE SPARKS" IN THE ANUS AND COLON AREAS. ADDITIONAL INFO WAS REQUESTED. SEE ALSO MFR# 3004209178201006687.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NJY151143H| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| EXPLANTED: