BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 2230844 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-04056
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    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 4 OF 5. REFERENCE: 1627487-2011-04053; 1627487-2011-04054; 1627487-2011-04055; 1627487-2011-04080. ON (B)(6) 2011, THE PT BEGAN A TRIAL IMPLANT WHICH INCLUDED 3 SURGICAL LEADS (2 FROM THE SAME LOT), TWO SURGICAL EXTENSIONS, AND AN ANCHOR. ON (B)(6) 2011, AN IPG WAS SCHEDULED TO BE IMPLANTED. THE PHYSICIAN NOTICED POSSIBLE SIGNS OF INFECTION. DERMATITIS WAS FOUND AT THE EXIT SITE OF THE EXTENSION. THE PHYSICIAN REMOVED THE EXTENSIONS AND IMPLANTED NEW EXTENSIONS. THE PHYSICIAN LEFT THE LEADS IMPLANTED, AND DID NOT IMPLANT THE IPG AT THIS TIME. THE OLD EXTENSIONS WERE DISCARDED. FOLLOW UP REVEALED THE PHYSICIAN PROVIDED PRE-OPERATION ANTIBIOTIC, ADN SUSPECTED THE PT HAD NOT FOLLOWED ANTIBIOTIC PROTOCOL OR PROPER HYGIENE. IT WAS REPORTED THE PT IS TO BE REIMPLANTED AT A LATER DATE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT-LOCK ANCHOR SPINAL CORD STIMULATION ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3282483

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention