BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3139390 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08438
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    January 28, 2013
    Report Date
    August 20, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V973529, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN DOWN HER LEG AND THE LEAD MIGRATED. THE HEALTH CARE PROVIDER DID A LEAD REVISION AND DURING THE SURGERY, THE NEW LEAD DID NOT FIT INTO THE IMPLANTABLE NEUROSTIMULATOR (INS). A NEW INS WAS USED. THE PATIENT¿S SYMPTOMS STARTED ¿ABOUT A WEEK¿ BEFORE THE REVISION. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240898 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention