BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL LEAD EXTENSION

    MDR report key: 2251175 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-08213
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 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

    EVAL: RESULTS - COMPLAINTS WERE CONFIRMED. AS RECEIVED, ONE OF THE LEADS AND THE EXTENSION FAILED CONTINUITY. THE EXTENSION FAILED FUNCTIONAL TESTING WITH OPENS AT CHANNELS 5-8. ALL OF THE CHANNELS OF THE LEAD WERE OPEN. THIS WOULD CAUSE HIGH IMPEDANCE IN THE LEADS WHICH WOULD RESULTS IN A LOSS OR DECREASE OF THERAPY. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-08205. THE PT RECEIVED THE SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST THE PAIN COVERAGE IN THE BACK. THE LEAD HAD HIGH IMPEDANCE. THE LEAD WAS AND THE EXTENSION WERE EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL LEAD EXTENSION SPINAL CORD STIMULATOR LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3343 2801917

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS LEAD: MODEL 3228 (2)