BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2831255 · Received November 6, 2012

    Report

    Report Number
    1627487-2012-03662
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 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

    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 6 OF 6. REF MFR REPORTS: 1627487-2012-03657, 1627487-2012-03658, 1627487-2012-03659, 1627487-2012-03660, 1627487-2012-03661. IT WAS REPORTED THE PT HAS A CULTURE CONFIRMED (B)(6) INFECTION AT THE MID-BACK INCISION SITE. IT IS UNK AT THIS TIME WHAT DEVICES ARE TO BE EXPLANTED. IT WAS ALSO REPORTED THE PT IS BEING TREATED WITH IV ANTIBIOTICS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3341 3732952

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R SCS IPG: MODEL 3788| IMPLANT DATE: