BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1190316 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06365
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    March 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES ON THE IPG OR THE EXTENSION. THE LEAD WAS STRETCHED/OVER-STRESSED AND THE #3 CONDUCTOR BROKE AT THE #3 WELD SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MAJOR FALL DOWN A FLIGHT OF FOURTEEN STEPS. SHE SUBSEQUENTLY EXPERIENCED SHOCKING SENSATIONS AT THE LEAD/EXTENSION CONNECTION SITE, A LOSS OF THERAPEUTIC EFFECT, PAIN, AND SENSORY CHANGES. IT WAS PRESUMED THAT DISLODGEMENT OF THE LEAD OR EXTENSION HAD OCCURRED. A SINGLE LATERAL VIEW X-RAY OF THE SACRUM AND COCCYX WAS OBTAINED. THE LEAD POSITION WAS CORRELATED WITH INTRAOPERATIVE FILMS TO EXCLUDE PARTIAL LEAD RETRACTION. THE IPG APPEARED "OFFSET". REPROGRAMMING WAS DONE AND NO ELECTRODE COMBINATIONS YIELDED EFFECTIVE STIMULATION, ONLY PAINFUL STIMULATION IN THE RECTAL AND TAILBONE AREAS. PALPATION OF THE EXTENSION AREA INTENSIFIED THE PAIN. THE DEVICE WAS EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3093 LOT# V054410 IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 3095 LOT# NAH033143V IMPLANTED