BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 2792014 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-11482
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS 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 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

    DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2012-11480. REFERENCE MFR REPORT: 1627487-2012-11481. IT WAS REPORTED THE PHYSICIAN HAD IDENTIFIED AN INFECTION AND EXPLANTED THE SYSTEM. IT WAS REPORTED THE CULTURES IDENTIFIED THE PT HAD A (B)(6) INFECTION AND SHE WAS HOSPITALIZED. THE PT WAS BEING TREATED WITH IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LOCK ANCHOR SCS ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3742238

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R