BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 3231599 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-12951
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    October 21, 2011
    Report Date
    October 21, 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 INFORMATION 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

    DEVICE 6 OF 6. REFERENCE MFR REPORT #1627487-2013-12946, 12947, 12948, 12949, 12950. IT WAS REPORTED THE PATIENT DID NOT HAVE EFFECTIVE STIMULATION. THE PATIENT BELIEVES THE SUB-CUTANEOUS LEADS, OFF LABEL USE, HAD CONNECTION ISSUES. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS AND EXTENSIONS. THE PATIENT REPORTED SHE DID NOT REGAIN EFFECTIVE STIMULATION. NOTE: THE IPG WAS REPORTED IN MFR REPORT #1627487-2013-12941.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321632 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3341 3161543

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other