BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3173833 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10499
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# J0340585V, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE LEAD WAS DAMAGED DURING AN EXPLANT PROCEDURE AND THE ¿ELECTRODES WERE LEFT IN THE PATIENT¿. THE REPORTER INDICATED THAT THE WIRES CAME OUT BUT THE ¿ELECTRODES¿ DID NOT. IT WAS LATER REPORTED THAT PATIENT WAS HAVING A BATTERY REPLACEMENT AS SHE HAD INITIALLY RECEIVED THE IMPLANTABLE NEUROSTIMULATOR APPROXIMATELY 7 YEARS PRIOR TO THE REPORT. THE OLD BATTERY AND EXTENSION WERE DISCONNECTED FROM THE ORIGINAL LEAD. WHEN AN ATTEMPT WAS MADE TO INSERT THE ORIGINAL LEAD INTO INS, IT WOULD ONLY GO ¿PARTIALLY DOWN THE CHANNEL¿. AFTER A NUMBER OF ATTEMPTS, THE PHYSICIAN DECIDED THAT A NEW LEAD WAS NEEDED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE OLD LEAD, IT BROKE. IT WAS AT THAT POINT THAT THE INITIAL REPORT WAS MADE. FOLLOWING THAT HOWEVER, THE PHYSICIAN WAS ABLE TO DISSECT DOWN PARTIALLY AND WAS ABLE TO GRAB AND REMOVE THE REMAINING PORTION OF THE LEAD SO IT WAS FULLY REMOVED. A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE NEW INS WITHOUT ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274250 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1