BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, 60CM

    MDR report key: 2092597 · Received May 9, 2011

    Report

    Report Number
    1627487-2011-00625
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    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 INFO 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

    THE PT REC'D AN SCS SYS ON (B)(6) 2010, INCLUDING AN IPG, PERCUTANEOUS LEAD, LEAD EXTENSION AND LEAD ANCHOR. IT WAS REPORTED THAT SHE INITIALLY LOST STIMULATION IN (B)(6) 2011, AND EFFECTIVE THERAPY WAS RECAPTURED VIA REPROGRAMMING. THE PT ALLEGEDLY LOST STIMULATION AGAIN ON (B)(6) 2011. AN X-RAY WAS PERFORMED AND A VISIBLE BREAK IN THE PT'S EXTENSION WAS OBSERVED. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A FUTURE DATE TO ADDRESS THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 60CM SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 3057355

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention SCS LEAD ANCHOR: MODEL 1192| SCS LEAD: MODEL 3183| SCS IPG: MODEL 3788| IMPLANT:| IMPLANT:| IMPLANT: