BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 3192057 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-01717
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 25, 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

    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 2 OF 4. REF MFR REPORTS: 1627487-2013-01716, 1627487-2013-01718, 1627487-2013-01721. IT WAS REPORTED THE PT HAS A SMALL OPENING IN HIS MID BACK AREA NEAR AN EXTENSION. THE PT HAS TWO SCS SYSTEMS AND IT IS UNK WHICH EXTENSION IS ERODING THROUGH THE SKIN. BOTH OF THE PT'S SCS SYSTEMS WERE REMOVED, CULTURES WERE TAKEN AND THE PT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281731 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3346 3349241

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other SCS IPG, MODEL 3716 (2)| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3189 (2)| SCS LEAD, MODEL 3166| SCS LEAD, MODEL 3166| IMPLANT DATE:| SCS LEAD, MODEL 3169