BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRICULAR CATHETERS

    MDR report key: 3199121 · Received June 28, 2013

    Report

    Report Number
    9612007-2013-00021
    Event Type
    Death
    Date Received
    June 28, 2013
    Date of Event
    December 6, 2012
    Report Date
    June 28, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER INTEGRA MEDICAL DEVICES INVOLVED: 91CM PERITONEAL CATHETER (PRODUCT ID: 9MZ101, LOT NUMBER 0128497), STAINLESS STEEL CONNECTOR (PRODUCT ID 901412, LOT NUMBER 0123679), STAINLESS STEEL CONNECTOR (PRODUCT ID 901411, LOT NUMBER 0127099). REVIEW OF DEVICE HISTORY RECORD: THE LIST OF IMPLANTS SHOWED THAT NONE OF THEM ARE SHUNTS FROM INTEGRA BUT CATHETERS AND CONNECTORS. THE DEVICE HISTORY RECORDS OF THE INVOLVED INTEGRA DEVICES WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. VENTRICULAR CATHETER CAT #951102A, LOT 0130059: THE BATCH WAS MANUFACTURED IN 09/2004 AND INCLUDED 50 PRODUCTS. PERITONEAL CATHETER CAT #9MZ101, LOT 128497: THE BATCH WAS MANUFACTURED IN 05/2004 AND INCLUDED 40 PRODUCTS. CONNECTOR CAT # 901411, LOT 0127099: THE BATCH WAS MANUFACTURED IN 03/2004 AND INCLUDED 60 PRODUCTS. CONNECTOR CAT # 901412, LOT 0123679: THE BATCH WAS MANUFACTURED IN 08/2003 AND INCLUDED 80 PRODUCTS. THE REVIEW OF COMPLAINTS AND SALES SINCE (B)(4) 2009 REVEALED NO COMPLAINT FOR ANY OF THE 4 REFERENCES INVOLVED.(B)(4). FROM THE AVAILABLE INFORMATION, INTEGRA COMPONENTS WERE CONNECTED TO A CODMAN MEDOS SHUNT SINCE (B)(4) 2005. NO ADDITIONAL INFORMATION IS AVAILABLE TO INTEGRA AS OF TODAY. ADDITIONAL QUESTIONS ARE BEING RAISED. IT IS UNK IF THE DEVICES INVOLVED IN THE REPORTED INCIDENT ARE EXPECTED TO BE RETURNED FOR EVAL. THE DEVICES ARE STORED AT THE DEPT OF FORENSIC MEDICINE IN (B)(6). AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    (B)(6) 2012; THE PT WAS FOUND UNRESPONSIVE AT HOME. PRONOUNCED DEAD AT THE EMERGENCY ROOM. SHUNT MALFUNCTION WAS DECLARED AS THE CAUSE. (B)(6) 2012: PT AUTOPSIED. THE IMPLANTS ARE KEPT AND STORED AT THE DEPT OF FORENSIC MEDICINE IN (B)(6). THERE ARE GOOD PHOTOS THAT CAN BE DISTRIBUTED IF NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296454 VENTRICULAR CATHETERS VALVE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 0130059

    Patients

    Seq Age Sex Outcome Treatment
    1 Death