BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2768117 · Received September 26, 2012

    Report

    Report Number
    2768117
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 26, 2012
    Manufacturer
    UNKNOWN
    Product Code
    OEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD AN INDWELLING VENTRICULOCARDIAC SHUNT. SHE PRESENTED FOR VOMITING AND INTERMITTENT LETHARGY. EVAL INCLUDED A SHUNTOGRAM AND CT. THE IMAGES REVEALED EVIDENCE OF A FRACTURE OF THE CARDIAC CATH JUST PROXIMAL TO IT'S ENTRANCE INTO THE VENOUS SYSTEM. THE SHUNT WAS EXTERNALIZED AND INTERVENTIONAL RADIOLOGY WAS REQUIRED TO OBTAIN THE PIECE OF BROKEN OFF CATH. PT A FEW DAYS LATER HAD TO HAVE A SHUNT REVISION WITH REMINERALIZATION INTO THE PERITONEAL CAVITY. REQUIRED A RIGHT UPPER QUADRANT LAPAROTOMY WITH PLACEMENT OF THE PERITONEAL PORTION OF THE VP SHUNT. OTHER REMARKS: OBTAINING OFF SITE RECORDS TO HELP IDENTIFY THE LOT #, WILL AMEND REPORT AND RESEND TO FDA AND WILL FORWARD TO MEDTRONIC AT THAT TIME. WORKING WITH (B)(6) AT MEDTRONIC, WHO WILL ASSIST IN ASSURING CORRECT ADDRESS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULOCARDIAC CATH OEX UNKNOWN 43418 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| R