BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2765412 · Received September 28, 2012

    Report

    Report Number
    3004209178-2012-08679
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Report Date
    August 30, 2012
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# V103841, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND LESS THAN 50% THERAPY RELIEF. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE EXPLANTED. WHEN THE PHYSICIAN REMOVED THE LEAD, THE LEAD WAS STRETCHED AND THE PLASTIC BROKE AWAY FROM THE ELECTRODES, LEAVING THEM IN PLACE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE LEADS. IT WAS REPORTED THAT THE INS AND LEAD WERE LOST AND WOULD NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY/NO ADVERSE EVENT. IT WAS REPORTED THAT THERE WAS NO PLAN TO REIMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1