BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3031594 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04515
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 8, 2013
    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
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093 LOT#, EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, PRODUCT #3093, FOUND ALL CONDUCTORS WERE BROKEN IN TWO LOCATIONS, 4.3 CM AND 5 CM FROM THE DISTAL END.

    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 A PATIENT WAS UNSTEADY ON HER FEET AND SUFFERED A FALL. IT WAS NOTED THAT THERE WAS BREAKAGE OF THE LEAD OR EXTENSION. THE REPORTER STATED THAT THE PATIENT HAD GOOD STIMULATION AND SYMPTOM RELIEF PRIOR TO THE FALL. THE PATIENT'S LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE EXPLANTED AND REPLACED. THE REPORTER STATED THAT THE INS WAS REPLACED BECAUSE, IT WAS ALREADY TWO YEARS OLD AND THE HEALTHCARE PROVIDER DID NOT WANT TO "COME BACK IN 12 MONTHS" TO REPLACE THE DEVICE IF IT EXPIRED TOO SOON. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED FULLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS VERY SKINNY AND FELL OVER "A BIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135074 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention