BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 3820913 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-03342
    Event Type
    Injury
    Date Received
    May 13, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. 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 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 5 OF 6. REF MFR REPORTS: 1627487-2014-03338, -03339, -03340, 03341 AND -03343. THE PT HAD 2 MODEL 3163 SCS LEADS (SAME LOT NUMBER), 4 MODEL 1192 SCS ANCHORS (SAME LOT NUMBER), AND 2 MODEL 3341, SCS EXTENSION (SAME LOT NUMBER). IT WAS REPORTED THE PT'S ORIGINAL SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287515 SWIFT LOCK ANCHOR SCS ANCHOR GZB ST JUDE MEDICAL - NEUROMODULATION 1192 3384071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other