BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS

    MDR report key: 1910745 · Received November 23, 2010

    Report

    Report Number
    2021898-2010-00323
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERITONEAL CATHETER PASSED THE PATENCY CHECK AND SHOWED NO ANOMALIES. THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT THE SYSTEM MAY BECOME INTERNALLY OCCLUDED DUE TO THE TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION, OR OTHER DEBRIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OCCLUSION. THE PT IS IN GOOD CONDITION AFTER REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS JXG MEDTRONIC NEUROSURGERY NA C58059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R CATALOG # 91503, LOT #C59863| CATALOG # 92866, LOT # C58346