BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3010576 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-12357
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 22, 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 LOST STIMULATION COVERAGE DUE TO LEAD MIGRATION. THE SJM REPRESENTATIVE WAS UNSUCCESSFUL MIGRATION. THE SJM REPRESENTATIVE WAS UNSUCCESSFUL IN REGAINING STIMULATION COVERAGE BY REPROGRAMMING. PATIENT WILL FOLLOW-UP ON THE ISSUES WITH THE PHYSICIAN. NOTE THE PATIENT HAS TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108428 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3416657

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS IPG, MODEL 3788| IMPLANT DATE: