BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2890922 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-14253
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 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

    MFR'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF SKIN EROSION COULD NOT BE CONFIRMED VIA LAB TESTING. 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 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2012-14251, REFERENCE MFR REPORT: 1627487-2012-14252. IT WAS REPORTED THE PT WAS EXPERIENCING SKIN EROSION OVER THE LEAD-EXTENSION CONNECTION SITE. THE PT'S LEAD AND EXTENSIONS WERE REPLACED WITH NEW ONES. THE PHYSICIAN MOVED THE IPG SITE TO THE RIGHT SIDE SINCE THE SCS SYSTEM WAS REROUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3168124

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R IMPLANT:| SCS IPG: MODEL 3788