BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2875114 · Received December 12, 2012

    Report

    Report Number
    1627487-2012-06920
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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: REVIEW OF THE DHR FOUND A NONCONFORMANCE 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

    THE PT HAS TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THAT PT EXPERIENCED SKIN EROSION AT THE LEAD SITE. ON (B)(6) 2012, THE DOCTOR IRRIGATED THE PT'S LEAD SITE. THE PT HAS BEEN TREATING THE WOUND WITH ANTIBIOTICS. THE LEAD SITE IS HEALING WELL, AND THE PT IS SCHEDULED FOR A F/U VISIT WITH HIS DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2769864

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| SCS ANCHORS: MODEL 1192 (2)| IMPLANT: