BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2100353 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03505
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNRELATED MEDICAL PROCEDURE. IT WAS STATED THE PATIENT WAS AT A PHYSICAL THERAPY SESSION WHEN THE THERAPIST PUT A "ESTIM ELECTRODE" OVER HER DEVICE. THE PATIENT EXPERIENCED A "SHOCKING TO THE POINT SHE WAS CONVULSIVE," AND THE PATIENT WAS FORCED TO TURN THEIR DEVICE OFF. THE PATIENT LATER HAD THEIR DEVICE CHECKED AND REPROGRAMMED BY THEIR HEALTH CARE PROVIDER, BUT THE PATIENT STATED IT WAS "NOT WORKING LIKE IT WAS PRIOR TO THE ESTIM INCIDENT." TROUBLESHOOTING WAS SUGGESTED, BUT NO PATIENT OUTCOME WAS REPORTED. THE PATIENT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 28 YR EXPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V383049| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD099920N| IMPLANTED: