BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD DELIVERY SYS, 19CM (7.5 IN), 1 EACH

    MDR report key: 5101420 · Received September 24, 2015

    Report

    Report Number
    1627487-2015-07562
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LHG
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT #: 1627487-2015-07563 AND 1627487-2015-07564. IT WAS REPORTED THE PATIENT UNDERWENT THE PERMANENT IMPLANT PROCEDURE ON (B)(6) 2015. DURING THE SURGERY, THE PHYSICIAN WAS UNABLE TO ACCESS THE EPIDURAL SPACE WITH THREE EPIDUCERS DUE TO THE PATIENT'S ANATOMY. THE PATIENT WAS EVENTUALLY IMPLANTED BUT THE PROCEDURE WAS EXTENDED FOR 45 TO 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633464 LEAD DELIVERY SYS, 19CM (7.5 IN), 1 EACH SCS EPIDUCER LHG ST. JUDE MEDICAL - NEUROMODULATION 1773 5062579

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other