BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2892241 · Received December 27, 2012

    Report

    Report Number
    1627487-2012-13272
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 6 OF 9. REFERENCE MFR REPORT: 1627487-2012-13267, 1627487-2012-13268, 1627487-2012-13269, 1627487-2012-13270, 1627487-2012-13271, 1627487-2012-13273, 1627487-2012-13274, AND 1627487-2012-13275. THERE ARE 5 LEADS FROM DIFFERENT LOT NUMBERS AND 3 EXTENSIONS FROM DIFFERENT LOT NUMBERS. IT'S UNDETERMINED WHICH LEAD OR EXTENSION WAS REMOVED. REPORTS FOR ALL LEADS AND EXTENSIONS ARE SUBMITTED. IT WAS REPORTED, THE PATIENT HAD IRRITATION AT THE IPG SITE. THE PHYSICIAN SUSPECTED INFECTION AND PLACED THE PATIENT ON ORAL ANTIBIOTICS. FOLLOW-UP IDENTIFIED THE PHYSICIAN REMOVED THE IPG AND ONE EXTENSION. ON LEAD WAS CUT WITH THE TERMINAL END LEFT IN PLACE. CULTURES TESTED NEGATIVE FOR INFECTION. FOLLOW-UP FOUND THE PATIENT HAD NO SIGNS OF INFECTION. PRIOR TO THE INFECTION, IT WAS NOTED THERE WERE IMPEDANCE ISSUES, AND THE AMPLITUDE WAS UNABLE TO BE INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3343 3108763

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention