BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2711957 · Received August 23, 2012

    Report

    Report Number
    3007566237-2012-02043
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Report Date
    July 26, 2012
    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

    PRODUCT ID 3889, BLUE_LEAD, LOT# V941208, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# V933654, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2012-02043. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889BLUE_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DAMAGED DURING THE PROCEDURE. THE LEAD WAS TO BE REPLACED. DURING A STAGE 2 TRIAL, THE PHYSICIAN NOTICED BLOOD IN THE LEAD BODY JUST BELOW THE CONTACTS. THE LEAD AND EXTENSION WERE BOOTED. THERE MAY HAVE BEEN A CRACK IN THE LEAD FROM THE RECOVERY OR REMOVAL PROCESS OF THE LEAD. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEADS WERE DAMAGED AND HAD HIGH IMPEDANCES. A NEW LEAD WAS PLACED AT THE TIME, AND EVERYTHING WAS WORKING "FINE."

    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