BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2993323 · Received March 7, 2013

    Report

    Report Number
    9614453-2013-00556
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND BOTH EXTENSIONS REVEALED THE FOLLOWING: "THE INS WAS RECEIVED WITH ONE EXTENSION DISCONNECTED FROM THE #0-3 CONNECTOR PORT AND THE OTHER EXTENSION STILL IN THE #4-7 CONNECTOR PORT. THE EXTENSION THAT HAD BEEN DISCONNECTED HAD INS SETSCREW IMPRESSIONS ON THE PROXIMAL CONNECTOR PINS INDICATING THAT THEY HAD BEEN TIGHTENED AT ONE TIME. THE EXTENSION IN THE #4-7 CONNECTOR PORT HAD THE #5-6 CONNECTOR PIN OF THE EXTENSION PARTIALLY PULLED OUT OF THE CONNECTOR PORT SO IT WAS NOT MAKING CONTACT WITH THE #5 CONNECTOR IN THE INS PORT. DURING REMOVAL OF THE EXTENSION FROM THE #4-7 CONNECTOR PORT, IT WAS NOTED THAT THE #6 SETSCREW WAS TOUCHING THE EXTENSION BUT WAS NOT TIGHT. IT WAS ALSO NOTED THAT THE #7 SETSCREW WAS TIGHT TO THE EXTENSION. AFTER REMOVING THE EXTENSION FROM THE #4-7 CONNECTOR PORT, IT WAS OBSERVED THAT THERE WERE SETSCREW IMPRESSIONS ON THE PROXIMAL CONNECTOR PINS INDICATING THAT THEY HAD BEEN TIGHTENED AT ONE TIME. THE INS SETSCREWS WERE TESTED WITH KNOWN GOOD EXTENSIONS PUT INTO THE PORTS AND THE SETSCREWS COULD BE TIGHTENED TO THE EXTENSIONS SO THAT THEY WERE HELD IN THE CONNECTOR PORT. IT APPEARS THAT EITHER SOME OF THE SETSCREWS WERE NOT TIGHTENED WELL AT IMPLANT OR POSSIBLY THEY LOOSENED AND THE PATIENT FALL CAUSED THE EXTENSIONS TO SHIFT IN THE INS PORTS. THE INS AND EXTENSIONS WERE FOUND TO BE FUNCTIONALLY OKAY." FINAL ANALYSIS OF LEAD 1 (3389) REVEALED THAT "THE #3 ELECTRODE WAS CRUSHED AND THE #3 CONDUCTOR BROKE OFF AT THE WELD SITE DUE TO OVERSTRESS/DAMAGE" AT THE DISTAL END. FINAL ANALYSIS OF LEAD 2 (UNKNOWN) REVEALED THAT THE PRODUCT HAD BEEN "CUT THROUGH" AND "SEGMENTED."

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2013-(B)(6), (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL. IT WAS ALSO REPORTED HIGH IMPEDANCES WERE MEASURED AND THE PHYSICIAN WANTED TO EXAMINE THE SYSTEM INTRAOPERATIVELY. DURING THE PROCEDURE, IT WAS REPORTED THE EXTENSION PLUGS WERE NOT COMPLETELY FIXATED IN THE BATTERY CONNECTOR. THE PATIENT'S DEVICE WAS REPORTED TO HAVE BEEN EXPLANTED DUE TO THE MECHANICALLY LOOSE CONTACT AND THE PATIENT WAS NOT SATISFIED WITH THE THERAPEUTIC EFFECT SINCE IMPLANTATION. IT WAS REPORTED THE PATIENT HAD NO SYMPTOMS OR INJURIES RELATED TO THE EVENT AND RECOVERED WITH NO INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97187 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 7427T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention