BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3192045 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-01724
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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

    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

    IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION. X-RAYS WERE TAKEN AND SHOWED THE LEAD SHIFTED TO THE RIGHT CAUSING UNINTENDED ABDOMINAL STIMULATION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 WHERE HIS LEAD WAS REPOSITIONED TO THE LEFT. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281630 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3941567

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788