BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1884618 · Received October 19, 2010

    Report

    Report Number
    3004209178-2010-08131
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    May 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    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

    IT WAS REPORTED THAT THE PT WAS "HAVING PROBLEMS" AND WANTED TO TRY REPROGRAMMING THE DEVICE. THE DEVICE WAS REPLACED, AND THE PT WAS NOT LONGER HAVING PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U 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 82 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD073885N| EXPLANTED:| LEAD: MODEL 3093, LOT# V126587| IMPLANTED:| IMPLANTED: