BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 30CM

    MDR report key: 2121004 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00789
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 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 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 SYS INCLUDING A LEAD EXTENSION ON (B)(6) 2007. IT WAS REPORTED THAT THE PT WAS WITHOUT STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO ADDRESS THIS PROBLEM. IT WAS DISCOVERED THAT HER EXTENSION WAS FRACTURED. THE IMPACTED EXTENSION WAS EXPLANTED. A SUBSEQUENT PROCEDURE WAS UNDERTAKEN ON (B)(6) 2011 TO IMPLANT THE PT'S NEW EXTENSION SINCE A REPLACEMENT DEVICE WAS NOT AVAILABLE DURING THE INITIAL SURGERY. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, DUAL 4 CHANNEL 30CM SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3343 R48137

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3716| SCS LEAD: MODEL 3240| IMPLANT: