BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3023210 · Received March 27, 2013

    Report

    Report Number
    9614453-2013-00577
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 8, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 309328, LOT# 0205704445, IMPLANTED: (B)(6) 2012-04, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3023 (LOT # NBV640027S) SHOWED NO ANOMALY FOUND. FINAL ANALYSIS OF LEAD MODEL 309328 SHOWED BODY/CONDUCTOR BROKEN AT OR NEAR TINES. FINAL ANALYSIS OF EXTENSION MODEL # 3095-10 (LOT # NAH055612V) SHOWED NO ANOMALY FOUND. FINAL ANALYSIS OF NEUROSTIM BOOT ACCESSORY SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF FECAL INCONTINENCE SYMPTOMS FOLLOWING A MINOR FALL THAT RESULTED IN A "BRISK HIP EX TENSION". IT WAS NOTED THAT THE PATIENT COULD FEEL ELECTRICAL SHOCKS IN HER BUTTOCKS AT TIMES. IT WAS STATED THAT THE PATIENT HAD "GOOD FUNCTIONAL" RESULTS PRIOR TO THE FALL. IT WAS ALSO STATED THAT THE PATIENT HAD GOOD RESULTS OF "SNM". IT WAS NOTED THAT DURING EXPLANT THE CONNECTION BETWEEN THE IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION LEAD WAS "MOVING". IT WAS STATED THAT IMPEDANCE RESULTS SUGGESTED A BROKEN LEAD. IT WAS ALSO NOTED THAT THERE WAS FLUID INSIDE THE INS PLUG AREA, THE CONNECTION BETWEEN THE EXTENSION AND THE LEAD WAS COVERED WITH PROVIDED BOOTS. REPORTEDLY, THIS WAS FULL OF "MILKY" FLUID. IT WAS STATED THAT THE STITCHES (TIES) WERE STILL IN PLACE AND THE SURGEON CUT THE TIP OFF OF THE LEAD FOR REMOVAL. IT WAS REPORTED THE PATIENTS INS, LEAD AND EXTENSION WERE EXPLANTED BUT IT WASN'T CLEAR IF ANYTHING IN ADDITION TO THE LEAD WAS REPLACED. THE PATIENT'S STATUS WAS UNKNOWN AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE SYSTEM WAS REPLACED. THE PATIENT HAD RECOVERED AND WAS RECEIVING EFFECTIVE STIMULATION AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125052 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention