BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2367766 · Received December 12, 2011

    Report

    Report Number
    3004209178-2011-09736
    Event Type
    Injury
    Date Received
    December 12, 2011
    Report Date
    November 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 SERIAL# (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. FUNCTIONAL TESTING WAS PERFORMED AFTER THE LEAD CONNECTOR SLEEVE WAS REMOVED. FUNCTIONAL OUTPUT TESTING SHOWED GOOD STABLE OUTPUT AT ALL ELECTRODE PAIRS. THERE WAS FOREIGN MATERIAL (SUSPECTED BODY FLUID) IN THE CONNECTOR PORTS. THERE WERE BURN MARKS ON THE CAN (SUSPECTED CAUTERY). THE SETSCREW WAS BACKED OUT TOO FAR AND DAMAGED THE TECOTHANE. THE GROMMET WAS DAMAGED AND REMOVED AS WELL. CIRCUIT #3 CONDUCTOR WIRE WAS BROKEN AT THE #3 CONNECTOR SLEEVE FROM OVERSTRESS. THE LEAD'S #3 CONNECTOR SLEEVE WAS STUCK IN THE INS PORT. ADDITIONAL ANALYSIS OF LEAD MODEL 3889 LOT# V141293 SHOWED NO SIGNIFICANT ANOMALIES. THE LEAD WAS SEGMENTED WITH INSULATION AND CONDUCTOR BOTH CUT THOUGH. CONTINUITY WAS ACCEPTABLE FROM THE CUT DISTAL END TO #0, 1, 2 CONNECTOR SLEEVES AND #3 BROKEN CONDUCTOR WIRE.

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889, LOT# V141293. IMPLANTED:2008 (B)(6), EXPLANTED: 2011 (B)(6). PROGRAMMER: MODEL 3037, LOT# NJD070328N. ANALYSIS OF THE NEUROSTIMULATOR MODEL 3058 (B)(6) SHOWED THAT LEAD OR LEAD PARTS WERE STUCK IN THE DEVICE CONNECTOR PORT. THERE WERE LOOSE OR MISSING GROMMETS, AND MISSING SETSCREWS, THAT WERE SUSPECTED DAMAGE DUE TO EXPLANT OF THE DEVICE. THE SETSCREWS WERE BACKED OUT TOO FAR. ANALYSIS OF THE LEAD MODEL 3889 LOT# V141293 SHOWED NO SIGNIFICANT ANOMALIES. THE PROXIMAL END OF THE LEAD WAS STRETCHED. THE #3 CONNECTOR SLEEVE WAS STUCK IN THE NEUROSTIMULATOR CONNECTOR PORT. THE #3 AT CONNECTOR SLEEVE WAS CUT (SUSPECTED EXPLANT DAMAGE). THE CONTINUITY WAS ACCEPTABLE WITH NO SHORTS BETWEEN CIRCUITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS TO BE REMOVED AND REPLACED DUE TO THE DEVICE'S END OF SERVICE (EOS). DURING THE REPLACEMENT SURGERY, THE SET SCREW "WOULD ONLY SPIN" AND COULD NOT BE EASILY REMOVED. EVENTUALLY, THE SET SCREW WAS REMOVED. HOWEVER, THE LEAD WAS STRETCHED WHILE ATTEMPTING TO EXTRACT IT FROM THE NEUROSTIMULATOR CONNECTOR BLOCK. THE CONNECTOR BLOCK WAS, THEN, IRRIGATED AS IT APPEARED THAT SOME BODY FLUID WAS PRESENT IN THE CONNECTOR BLOCK. IN PULLING OUT THE LEAD, THE LEAD WAS "COMPROMISED" BY THE PROCESS. ALL PARTS OF THE LEAD WERE EXPLANTED. THERE WAS NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention