BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3872112 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11536
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3093-28, LOT# V195597, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V195597, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED SINCE IMPLANT THE PATIENT HAD TROUBLE WITH THEIR STIM THERAPY SINCE IMPLANT. THE PATIENT HAD A FALL IN (B)(6) 2013 AND THE WHOLE SYSTEM SHIFTED OVER AND WAS CAUSING PATIENT PAIN AT THE NEUROSTIMULATOR (INS) SITE. IT WAS INDICATED THAT PATIENT WAS DOING BETTER WITH STIMULATION OFF DUE TO PAIN AT INS SITE, THEY EXPLANTED SYSTEM. IT WAS NOTED THAT PART OF LEAD LEFT IN WHEN SYSTEM WAS REMOVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349592 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention