BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5039413 · Received August 28, 2015

    Report

    Report Number
    3004209178-2015-16939
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Report Date
    July 31, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT # V183296, REVEALED NO SIGNIFICANT ANOMALY; # 0 AND # 1 CONDUCTORS WERE BROKEN DUE TO OVERSTRESS/DAMAGED AT THE DISTAL END OF THE SEGMENT.

    Additional Manufacturer Narrative · 1

    (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'S IMPLANT STOPPED WORKING SIX MONTHS PRIOR TO THE REPORT. SHE WENT TO HER DOCTOR THREE MONTHS PRIOR TO THE REPORT AND THEY CHECKED THE IMPLANT, DETERMINING THAT HER IMPLANT BATTERY DEPLETED. THE PATIENT WAS TO HAVE SURGERY IN A FEW MONTHS TO REPLACE THE IMPLANT. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTS THE LEAD WAS BEING REMOVED AND ELECTRODE PORTION BROKE OFF AT BONE TABLE. PHYSICIAN WANTS TO KNOW IF ALL WIRES WERE REMOVED. THE INDICATION-FOR-USE (IFU) WAS FOR NEUROSTIMULATOR OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573152 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR