BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3133345 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-05711
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 IS NOT RECEIVING ADEQUATE COVERAGE. THE PATIENT ALSO EXPERIENCED PAIN DOWN HER LEFT ARM WHEN SHE ACTIVATED STIMULATION. AN IMPEDANCE CHECK REVEALED SEVERAL INVALID CONTACTS. X-RAYS SHOWED ONE END OF THE LEAD HAS MIGRATED AND THE OTHER END IS FRACTURED. AS A RESULT, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223550 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3650553

    Patients

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