BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 2820152 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02594
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ST. JUDE MEDICLA - 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 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 INFORMATION 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 1 OF 4. REFERENCE MFR REPORTS: 1627487-2012-02595, 02596, 02597. IT WAS REPORTED THE PT DEVELOPED INFECTION AT THE ANCHOR SITE. THE PHYSICIAN REMOVED THE PT'S ENTIRE SYSTEM ON (B)(6) 2012. IT WAS REPORTED THE PT WAS TREATED WITH ANTIBIOTICS. FOLLOW-UP IDENTIFIED CULTURE RESULTS SHOWED (B)(6) INFECTION. THE PHYSICIAN REPORTED THE PT IS CURRENTLY IN A PHYSICAL REHABILITATION FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR SCS LEAD ANCHOR GZB ST. JUDE MEDICLA - NEUROMODULATION 1192 3511196

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: