BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, 60CM

    MDR report key: 2140944 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-00852
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: AS RECEIVED, BOTH EXTENSIONS SHOWED BROKEN WIRES AT THE STRAIN RELIEF OF THE HEADER. DUE TO THE BROKEN WIRES, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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 (B)(6) RECEIVED AN SCS SYSTEM INCLUDING TWO LEAD EXTENSIONS. IT WAS REPORTED THAT THE PT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS ON BOTH EXTENSIONS. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE DEVICES. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 60CM SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 173421

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL: UNKNOWN| SCS LEAD: MODEL: UNKNOWN| IMPLANTED:| IMPLANTED: