BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1962678 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-01038
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NON-CONFORMANCE; HOWEVER, THE NON-CONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE. PRODUCT WAS REWORKED AND APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. THE LEAD WAS NOTED AS SEVERELY KINKED WITH ALL WIRES BROKEN APPROXIMATELY 9 CM FROM THE STIMULATION END. THE LEAD HAD MULTIPLE COMPRESSION DAMAGE ALONG THE LEAD SEGMENT OUTER TUBING NEAR THE STIMULATION END. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT ((B)(6)) RECEIVED AN SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION, AND STIMULATION COULD NOT BE TURNED UP TO PERCEPTION. IMPEDANCE CHECKS REVEALED HIGH IMPEDANCE VALUES ON ALL LEAD CONTACTS. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2010. IT WAS REPORTED THAT EFFECTIVE STIMULATION WAS RECEIVED POST-OPERATIVE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3143 3092382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention