BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTORDE

    MDR report key: 2921942 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-05049
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    THE PATIENT HAD TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THE PATIENT EXPERIENCED REDNESS AND PAIN AT THE LEAD SITE. THE PATIENT WAS PUT ON ANTIBIOTICS AS A PRECAUTION. ON (B)(6) 2012, THE DOCTOR OPENED THE PATIENT'S INCISION AND AN INFECTION WAS FOUND AT THE LEAD SITE. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED. THE DOCTOR GAVE THE PATIENT AN ANTIBIOTIC SHOT AND WILL MEET WITH THE PATIENT FOR FOLLOW-UP. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5937 OCTORDE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 (X2) 3808659

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT:| SCS ANCHORS: MODEL 1192 (X2)| EXPLANT: