BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH

    MDR report key: 5101431 · Received September 24, 2015

    Report

    Report Number
    1627487-2015-07564
    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 3 OF 3. REFERENCE MFR REPORT #: 1627487-2015-07562 AND 1627487-2015-07563.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632238 LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH SCS EPIDUCER LHG ST. JUDE MEDICAL - NEUROMODULATION 1772 4912592

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other