BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CATHETER

    MDR report key: 9764409 · Received February 27, 2020

    Report

    Report Number
    2021898-2020-00070
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 23, 2011
    Report Date
    February 27, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SOHEILA RAYSI DEHCORDI & CLAUDIO DE TOMMASI & ALESSANDRO RICCI & SARA MARZI & CRISTINA RUSCITTI & GIANFRANCO AMICUCCI & RENATO J. GALZIO. LAPAROSCOPY-ASSISTED VENTRICULOPERITONEAL SHUNT SURGERY: PERSONAL EXPERIENCE AND REVIEW OF THE LITERATURE. NEUROSURGICAL REVIEW 34 (2011). DOI 10.1007/S10143-011-0309-6. ABSTRACT VENTRICULOPERITONEAL SHUNTING IS A WIDELY ACCEPTED TECHNIQUE FOR THE TREATMENT OF HYDROCEPHALUS. THE STANDARD PROCEDURE TO INSERT THE PERITONEAL CATHETER REQUIRES AN ABDOMINAL INCISION, MUSCLE DISSECTION, AND OPENING OF THE PERITONEUM. A NUMBER OF COMPLICATIONS RELATED TO THE ABDOMINAL SURGICAL PHASE HAVE BEEN REPORTED. LAPAROSCOPY ASSISTED VENTRICULOPERITONEAL SHUNTING IS A VALID ALTERNATIVE PROCEDURE THAT REDUCES SURGICAL TRAUMA. WE DESCRIBE OUR EXPERIENCE AND REVIEW THE LITERATURE. A TOTAL OF 30 LAPAROSCOPICALLY GUIDED VENTRICULOPERITONEAL SHUNTING PROCEDURES WERE PERFORMED BETWEEN JANUARY 2007 AND JUNE 2008, IN COLLABORATION WITH A GENERAL SURGEON EXPERIENCED IN LAPAROSCOPY. OF THESE PROCEDURES, 25 WERE NEW SHUNT PLACEMENTS AND 5 WERE REVISIONS. DATA ABOUT OPERATIVE TIME, OUTCOME, AND COMPLICATIONS WERE REGISTERED AND COMPARED WITH A GROUP OF 30 PATIENTS TREATED BY MEANS OF STANDARD LAPAROTOMY IN THE PERIOD 2005¿2007. LAPAROSCOPIC SHUNT PLACEMENT WAS SUCCESSFUL IN ALL PATIENTS. OPERATIVE DURATION, COMPLICATIONS, AND POSTOPERATIVE PAIN WERE ALL LOWER IN PATIENTS TREATED BY LAPAROSCOPY AS COMPARED TO THE LAPAROTOMY. IN THE LAPAROSCOPIC GROUP, AN EARLIER PERISTALSIS, QUICKER MOBILIZATION, AND BETTER COSMETIC RESULTS WERE ALSO NOTED. LAPAROSCOPY IN BOTH VENTRICULOPERITONEAL SHUNT PLACEMENT AND REVISION IS A SAFE, EFFECTIVE, AND MINIMALLY INVASIVE TECHNIQUE. IT ENSURES PROPER ABDOMINAL PLACEMENT OF THE DISTAL CATHETER UNDER DIRECT VISION ALLOWING CONFIRMATION OF ITS PATENCY. REPORTED EVENTS. - THE IMMEDIATE COMPLICATION OF THE NLG WAS 1 PATIENT HAD A PROXIMAL MALFUNCTION OF THE CATHETER. - THE SHORT-TERM COMPLICATION OF THE NLG WAS 1 PATIENT HAD A MALFUNCTION RELATED TO THE PRESENCE OF A COILING IN THE DISTAL CATHETER. - THE LONG-TERM COMPLICATIONS OF THE NLG WERE 2 PROXIMAL COMPLICATIONS AND 1 OBSTRUCTION OF THE DISTAL CATHETER TO SEVERE PERITONEAL ADHESIONS. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224982 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1