BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2120954 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00787
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    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 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 AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S STIMULATION COVERAGE WAS INEFFECTIVE AS HE IS NOT FEELING THERAPY ON HIS LEFT SIDE. A CT SCAN REVEALED THAT THE PT'S LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPOSITION THE DEVICE AND EFFECTIVE THERAPY COVERAGE WAS CAPTURED FOR THE PT AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3296508

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788