BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2485547 · Received March 9, 2012

    Report

    Report Number
    3007566237-2012-00507
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    February 14, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3587A LOT# UNKNOWN IMPLANTED UNK EXPLANTED UNK.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. THE INITIAL MDR WAS FILED AS MFR REPORT #3007566237-2012-00507. ADDITIONAL INFORMATION INDICATED THE CORRECT MANUFACTURING SITE WAS SITE #9614453.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR MODEL 3023 (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY WAS NOT IN NEW CONDITION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT STIMULATION HAD BEEN SET BETWEEN 5 AND 6 VOLTS. THE IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CUT PRIOR TO IMPLANT, THUS ONLY ELECTRODES 0 AND 1 WERE IN OPTIMAL CONDITION. ELECTRODE 0 WAS NEGATIVE AND CASE WAS POSITIVE. THE NEUROSTIMULATOR WAS IMPLANTED ABOUT 1 YEAR PRIOR TO REPORT. THE PATIENT WAS PROGRAMMED AT 6V, 210 PW, AND 14 HZ. A LONGEVITY ESTIMATION USING THOSE SETTINGS SHOWED END OF SERVICE AT AN ESTIMATED 23.9 MONTHS. THE BATTERY WAS LOW AND A REPLACEMENT WAS SCHEDULED FOR (B)(6)-2012. IMPEDANCES WERE WITHIN NORMAL LIMITS. THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention