BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2890822 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-06984
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 1 OF 2. REF MFR REPORT: 1627487-2012-06985. ON (B)(6) 2012, THE PT UNDERWENT A PERMANENT IMPLANT PROCEDURE. IT WAS REPORTED THE PT BEGAN SQUIRMING ON THE OPERATING ROOM TABLE WHEN HE WAS FIRST SEDATED. IT WAS ALSO REPORTED THE PT EMITTED A LOT OF SECRETIONS FROM THE NOSE AND MOUTH AFTER NUMBING MEDICINE WAS INJECTED AT THE INTENDED IPG AND LEAD SITE. AS A RESULT, THE CASE WAS ABORTED. NO INCISIONS WERE MADE AND NO PRODUCTS WERE IMPLANTED OR OPENED. THE PRODUCT THAT WAS INTENDED TO BE IMPLANTED WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention