BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2092670 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-00628
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 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 WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT LOST STIMULATION FOLLOWING A NEAR FALL. INITIAL EFFORTS TO RECAPTURE EFFECTIVE STIMULATION VIA REPROGRAMMING YIELDED LIMITED SUCCESS. AN X-RAY REVEALED THAT THE PT'S LEAD HAD MIGRATED. THE PT WAS REPROGRAMMED AND IS NOW SAID TO BE RECEIVING ADEQUATE THERAPY FROM 4 OF HIS 6 SET PROGRAMS. AS SUCH, THERE ARE NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME.

    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 3290704

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: