BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2101736 · Received May 10, 2011

    Report

    Report Number
    3004209178-2011-03384
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    June 1, 2009
    Report Date
    April 19, 2011
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING SENSATION WHICH STARTED "DAYS" AFTER IMPLANTATION. THE SHOCKING WAS NOTED AS GENERAL NATURE AND WAS NEAR THE VAGINAL AREA. SHE WAS TOLD TO TURN THE DEVICE OFF IN (B)(6) 2009 TO (B)(6) 2010 TIME FRAME BY ANOTHER PHYSICIAN SINCE THE DEVICE WAS NOT APPROVED FOR THE PATIENT'S DIAGNOSIS. THE PATIENT WAS GOING TO FOLLOW UP WITH ANOTHER PHYSICIAN TO DETERMINE THE NEXT STEPS. ADDITIONAL INFORMATION WAS REQUESTED. SEE ALSO MANUFACTURER REPORT # 3004209178-2011-03382.

    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 74 YR EXPLANTED:| IMPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL 3023,| LOT# NBV139802H| PROGRAMMER: MODEL 3037, LOT# NJD086488N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V252821| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH033406V| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD087322N| IMPLANTED:| LEAD: MODEL 3093, LOT# V252821| IMPLANTED: