BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-LUMBOPERITONEAL CATHETER SYSTEM

    MDR report key: 1750707 · Received June 29, 2010

    Report

    Report Number
    2021898-2010-00136
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    April 26, 2010
    Report Date
    June 2, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    MEDWATCH# (B) (4) WAS REC'D ON 6/2/10. IT WAS REPORTED THAT THE PT HAD SURGERY FOR A FIVE LEVEL DECOMPRESSIVE LAMINECTOMY WITH DUROTOMY AND THE EXCISION OF A SPINAL CORD SYRINGOSTOMY AND PLACEMENT OF A SYRINGO-SUBARACHNOID SHUNT AT THIS HOSPITAL IN 1996. THE PT RECENTLY BEGAN TO HAVE ABDOMINAL COMPLAINTS WITH A CHANGE IN BOWEL HABITS; CT SCAN DONE (B) (6) 2010 REVEALED EVIDENCE OF DISRUPTION OF THE LUMBOPERITONEAL SHUNT IN THE ABDOMINAL WALL MUSCULATURE OR JUST AT THE PERITONEAL LEVEL. THE PT WAS ADMITTED AND TAKEN TO THE OR (B) (6) 2010 FOR LAPAROTOMY, EVALUATION OF THE COLON AND RECTUM, AND REMOVAL OF THE FRACTURED CATHETER FROM; POSTOPERATIVE DIAGNOSIS DOCUMENTED FRACTURE OF LUMBOPERITONEAL SHUNT WITH DISCONNECTED SEGMENT OF THE CATHETER LYING ALONG THE LEFT COLON AND SIGMOID EXTENDING DOWN INTO THE PELVIS AGAINST THE RECTUM. THE PT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-LUMBOPERITONEAL CATHETER SYSTEM JXG MEDTRONIC NEUROSURGERY NA A4730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R