BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3821061 · Received May 9, 2014

    Report

    Report Number
    1627487-2014-00272
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    July 8, 2013
    Report Date
    April 14, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS- REVIEW OF THE DHR FOUND A NON CONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 2 OF 2. REFERENCE MFR REPORT NUMBER: 1627487-2014-00271. THE PATIENT (B)(6) IS A PARTICIPANT IN A CLINICAL STUDY AND WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE TIPS OF BOTH LEADS. THE DISCOMFORT WAS ATTRIBUTED TO LEAD MIGRATION. AN INFECTION WAS SUBSEQUENTLY DIAGNOSED AT THE RIGHT LEAD SITE. THE DEVICE HAD ALSO REPORTEDLY PERFORATED THE SKIN. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT THE PATIENT'S LEADS. IT WAS REPORTED THE INFECTION AND PAIN HAVE SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282191 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3183 3847500

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3386 (2)