BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH LEAD ANCHOR

    MDR report key: 2160697 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-00926
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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 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 4. REFERENCE MFR REPORT #S 1627487-2011-00923, 1627487-2011-00924 AND 1627487-2011-00925. THE PT ((B)(6)) RECEIVED AN SCS SYSTEM ON (B)(6) 2011 INCLUDING AN IPG, PERCUTANEOUS LEAD, LEAD EXTENSION AND LEAD ANCHOR. IT WAS REPORTED THAT HIS SCS SYSTEM WAS EXPLANTED ON AN UNK DATE DUE TO INFECTION. PRIOR TO THE SYSTEM'S REMOVAL, THERE WAS REPORTEDLY PUSS OOZING FROM THE ENTRY POINTS. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH LEAD ANCHOR SPINAL CORD STIMULATION LEAD ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1194 3117707

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R