BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLE 60-CM LENGTH PADDLE LEAD

    MDR report key: 2181338 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-03319
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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

    MIGRATION EVENT CANNOT BE CONFIRMED THROUGH PRODUCT ANALYSIS. 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 A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PT FELL YEARS AGO AND THERE WAS NO COVERAGE FOR THE PAIN AREA. AN X-RAY INDICATED THE LEAD HAD MIGRATED. THE LEAD AND IPG WERE REPLACED AND STIMULATION WAS CAPTURED POSTOPERATIVE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 60-CM LENGTH PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 116192

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| SCS LEAD: MODEL 3228| IMPLANT: