BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 CHANNEL LEAD EXTENSION, 30 CM

    MDR report key: 2230813 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-07113
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 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 A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT HAS NO STIMULATION. X-RAY OF THE SYSTEM SHOWED BOTH LEADS HAVE PULLED OUT OF THE EXTENSION HEADERS. ONE TAIL OF THE LEAD WAS NO LONGER INSERTED INTO THE EXTENSION, IT APPEARED THAT THE MOST DISTAL CONTACT ON ONE OF THE LEAD TAILS WAS GONE. DOCTOR FELT IT WAS SAFER FOR THE PT TO KEEP THE EXISTING LEAD AND USE NEW EXTENSIONS. THE EXTENSIONS WERE TESTED INTRA OPERATION AND THEY WERE ABLE TO GET PARASTHESIA COVERAGE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 CHANNEL LEAD EXTENSION, 30 CM SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3290643

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3219| SCS IPG: MODEL 3788| IMPLANT: