BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR CATHETER, SNAP, WITH BIOGLIDE, 7CM

    MDR report key: 3971832 · Received July 31, 2014

    Report

    Report Number
    2021898-2014-00273
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF THE CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED CATHETER MET THE REQUIREMENTS FOR PATENCY AND LEAK TESTING. THERE WERE NO ANOMALIES NOTED. IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THAT THE PATIENT HAD A SHUNT IMPLANTED IN 2009 AND HAD AN ISSUE WITH IT IN 2011; HOWEVER, THE SHUNT WAS REPAIRED. ACCORDING TO THE REPORT, RECENTLY THE PATIENT¿S SHUNT WAS REMOVED. THE REPORT STATED THAT AN ENDOSCOPE WAS USED TO RETRIEVE THE VENTRICULAR END FROM THE VENTRICLE. REPORTEDLY, NO ADVERSE EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446935 VENTRICULAR CATHETER, SNAP, WITH BIOGLIDE, 7CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C25045

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R