BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4441676 · Received January 22, 2015

    Report

    Report Number
    3004209178-2015-01074
    Event Type
    Injury
    Date Received
    January 22, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 5, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V060645, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD BROKE DURING THE EXPLANT PROCEDURE. IT WAS NOTED THAT THE MEDICAL DOCTOR REMOVED THE BATTERY AND PULLED THE LEAD BACK TO THE SACRUM, ATTEMPTING TO REMOVE IT AS THE MANUFACTURE RECOMMENDS BY DISSECTING DOWN TO THE SACRUM. THREE DAYS AFTER THE INITIAL REPORT, IT WAS REPORTED THAT THE DISTAL SEGMENT OF THE LEAD WITH FOUR ELECTRODES WAS STILL IN THE PATIENT. THE DOCTOR HAD DISCARDED THE BATTERY AND THE PROXIMAL SEGMENT OF THE LEAD. THE LEAD ISSUE OCCURRED AT THE DISTAL END WITH ALL ELECTRODES INCLUDED AT THE SEGMENT WHERE THE LEAD ENTERS THE SACRUM. INTERVENTIONS INCLUDED USING A KELLY CLAMP TO CLIMB DOWN THE LEAD WITH GENTLE TRACTION; THE LEAD WAS NOT MOVING. LIVE FLUOROSCOPY WAS USED, AND NO MOVEMENT OF THE LEAD WAS NOTED. THEY WERE UNABLE TO EXPLANT THE LEAD. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51637 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other