BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR CATH. ACCESS KIT (LCAK)

    MDR report key: 4101674 · Received August 27, 2014

    Report

    Report Number
    9612007-2014-00025
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 16, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K910853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER PUNCTURE AT THE CONNECTOR SITE. THERE WAS PT CONTACT BUT NO PT INJURY OR DEATH ALLEGED. PRODUCT REVISION WAS UNK. ADDITIONAL INFO WAS REQUESTED AND ON (B)(6) 2014, THE FOLLOWING WAS PROVIDED BY THE CUSTOMER. THE PT HAD A TYPE III THORACOABDOMINAL AORTIC ANEURYSM STATUS POST FENESTRATED ENDOVASCULAR REPAIR ALONG WITH STENTING OF THE LEFT RENAL, SUPERIOR MESENTERIC, AND CELIAC ARTERIES. SPINAL DRAIN PLACEMENT FOR MGMT OF SPINAL CORD PERFUSION. ON (B)(6) 2014 (1:00 AM ON POST-OPERATIVE DAY 1), THE NURSE TURNED THE PT AND THE BED WAS SOAKED. THE PT WAS NOT INCONTINENT SO THE NURSE INSPECTED THE SPINAL DRAIN AND FOUND IT TO BE PUNCTURED. THE SPINAL DRAIN WAS PULL OUT AND DISCONTINUED. PRODUCT LOT NUMBER UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522651 LUMBAR CATH. ACCESS KIT (LCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R