BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 60-CM LENGTH LEAD

    MDR report key: 2210417 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-04020
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THE PT CANNOT INCREASE STIMULATION PAST PERCEPTION. ATTEMPTS TO CORRECT THE ISSUE REVEALED IMPEDANCE ISSUES WITH SOME OF THE CONTACTS ON THE SCS LEAD. AN X-RAY WAS PERFORMED AND IT WAS REPORTED THAT THERE IS A POTENTIAL KINK IN THE LEAD, 10 CM FROM THE STIMULATION END. THE PT'S PHYSICIAN WILL DETERMINE IF REVISION IS NEXT COURSE OF ACTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 60-CM LENGTH LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3280557

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: