BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2877086 · Received December 11, 2012

    Report

    Report Number
    1627487-2012-12764
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WITHOUT STIMULATION COVERAGE. REPROGRAMMING WAS UNSUCCESSFUL AS X-RAYS REVEALED THE LEAD HAD MIGRATED. THE PATIENT WILL MEET WITH THE PHYSICIAN TO DETERMINE NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3704909

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788