BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3062652 · Received April 17, 2013

    Report

    Report Number
    3007566237-2013-01315
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V672426, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. ADDITIONAL INFORMATION DETERMINED THAT THE CORRECT MANUFACTURING SITE FOR THIS EVENT IS SITE # (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V672426, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 NOTED THAT ALL IMPEDANCES WERE WITHIN NORMAL RANGE. DIFFERENT PROGRAM SETTINGS WERE TRIED AND THE PATIENT STILL DID NOT RECEIVE SYMPTOM RELIEF. CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT WS GETTING GOOD SYMPTOM RELIEF WITH NEW LEAD AND NEW INS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD REVISION DUE TO LACK OF EFFICACY WITH LEAD. SYMPTOMS HAD RETURNED AND MULTIPLE PROGRAMMING CHANGES HAD BEEN MADE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164068 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention