BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUATTRODE

    MDR report key: 3221779 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-15924
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    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

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15925. THE PATIENT HAS 4 LEADS (2 FROM 1 LOT AND 2 FROM ANOTHER LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT'S LEAD ERODED THROUGH THE SKIN. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE ISSUE WAS RESOLVED. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313734 IUATTRODE SCS LEAD LGW ST. JUDE MEDICAL, NEUROMODULATION 3149 3629523

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS EXTENSION: MODEL 3346 (2)| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: