BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 3851402 · Received May 22, 2014

    Report

    Report Number
    1627487-2014-00311
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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 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 3 OF 3. REFERENCE MFR REPORT #'S 1627487-2014-00309 AND 1627487-2014-00310. THE PT'S (B)(6) THERAPY SYSTEM INCLUDES THREE PERCUTANEOUS LEADS FROM TWO DIFFERENT LOTS AND A LEAD EXTENSION. IT WAS REPORTED THE PT SUFFERED A FALL CAUSING TRAUMA TO THE BASE OF THE SKULL. FURTHER MEDICAL REVIEW FOUND AN INFECTION AND EXPOSURE OF THE LEAD AT THE SUBOCCIPITAL REGION (OFF-LABEL). SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306166 DUAL EXTENSION SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3341 3652594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANT DATE:| SCS LEAD, MODEL: 3788,