BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE 8 LEAD EXTENSION, 60 CM

    MDR report key: 1790916 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01540
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    January 17, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS. AND NO ANOMALIES WERE FOUND. EXTENSION HEADER HAS ALL WIRES BROKEN AND PULLED BACK INTO STRAIN RELIEF. THERE HAS BEEN SOME TYPE OF OVERSTRESS (UNKNOWN) WHICH DAMAGED AND BROKE THE WIRES IN THE EXTENSION. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT¿S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR¿S REPORT: 1627487-2010-01541. THE PT RECEIVED HIS SCS SYSTEM INCLUDING AN IPG, LEADS AND EXTENSIONS ON (B)(6) 2007. IT WAS REPORTED THAT THE PT COULD NOT INCREASE THE AMPLITUDE OF THE STIMULATION USING THE PROGRAMMER. DIAGNOSTIC TESTING SHOWED INVALID CONTACTS ON THE LEAD. THE PT WAS REPROGRAMMED AROUND THE INVALID CONTACTS UNTIL ALL CONTACTS BECAME INVALID. THE LEADS WERE TESTED PRIOR TO LEAD REPLACEMENT AND THE LEADS WERE FOUND TO BE FUNCTIONAL. WHEN TESTED WITH THE EXTENSIONS, THE LEADS SHOWED INVALID CONTACTS. REPLACEMENT OF THE EXTENSIONS RESOLVED THE ISSUE. THE EXPLANTED EXTENSIONS WERE RETURNED TO ANS FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 LEAD EXTENSION, 60 CM SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3386 67499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention