BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PETERLAZIC (ANSPACH)

    MDR report key: 2788120 · Received October 10, 2012

    Report

    Report Number
    MW5027228
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    June 26, 2012
    Report Date
    September 18, 2012
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED FOR CRANIOTOMY FOR ANEURYSM REPAIR ON (B)(6) 2012. PROCEDURE COMPLICATED BY FAILURE OF THE ANEURYSM CLIP APPLIER AND RUPTURE OF THE L AND R SIDE OF THE DISTAL INTERNAL CAROTID ARTERY NEAR THE BIFURCATION. THE RUPTURE AND SUBSEQUENT REPAIR RESULTED IN >45MIN ISCHEMIA. PT SUBSEQUENTLY HAD 14 DAY INPATIENT STAY COMPLICATED BY NEED FOR TRACHEOSTOMY AND PEG TUBE PLACEMENT. PARTIAL L 3RD NERVE PALSY AND L SIDED WEAKNESS. DISCHARGED TO REHAB FACILITY ON (B)(6) 2012. READMITTED ON (B)(6) 2012 FOR REVISION OF R CRANIOTOMY SITE FOR INSPECTION FOR FLUID LEAK, CULTURE OF FLUID AND STERILIZATION OF BONE FLAP D/T PERSISTENT FLUID COLLECTION UNDER THE SCALP INTERFERING WITH OPENING OF THE EYE. D/C BACK TO NEURO-REHAB FACILITY (B)(6) 2012, LAST SEEN BY NEURO-SURGEON (B)(6) 2012 (11 WEEKS POST INITIAL PROCEDURE) NOTES STATE "SIGNIFICANTLY IMPROVED WITH NORMAL L SIDED STRENGTH, NEEDS GAIT TRAINING (LAST FUNCTION FOR INDEPENDENCE). LEFT 3RD NERVE IS SLOWLY IMPROVING AS THERE IS SOME CONCENTRAL MOVEMENT AND PUPILLARY FUNCTION. PEG TUBE D/CED." PT CONTINUES ADMIT TO REHAB FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PETERLAZIC (ANSPACH) ANEURYSM CLIP APPLIER HCH PETER LAZIC GMBH 45.441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R ANEURYSM CLIPS