BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2201717 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06099
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 12, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE INS IMPLANTED IN (B)(6) 2010 "DID NOT WORK" AND A SECOND INS WAS IMPLANTED IN (B)(6) 2010 (THE LEAD WAS DISCONNECTED FROM THE FIRST IMPLANT). THE FIRST INS WAS NOT EXPLANTED.

    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 75 YR Required Intervention EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V413613| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD098892N