BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE HAKIM PROGRAMMABLE SANS

    MDR report key: 3552123 · Received January 6, 2014

    Report

    Report Number
    1226348-2014-10170
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    November 14, 2013
    Manufacturer
    CODMAN & SHURTLEFF, MEDOS
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE CATHETER WAS CUT. THIS COULD BE DUE TO THE CATHETER COMING IN CONTACT WITH A SHARP OR POINTED OBJECT DURING IMPLANT OR EXPLANT HOWEVER THIS COULD NOT BE CONFIRMED. AS NOTED IN THE IFU, CATHETERS HAVE A LOW CUT AND TEAR RESISTANCE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    DURING IMPLANTATION SURGERY VIA V-P SHUNT ON (B)(6) 2013, IT WAS NOTED THE VENTRICULAR CATHETER BROKEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. (B)(4) - THANK YOU FOR YOUR INQUIRY. AS OF TODAY, NO DELAY GREATER THAN 30MIN WAS REPORTED. (B)(4) 2014 BASED ON THE NEW MATRIX THAT WENT INTO EFFECT ON (B)(4) 2013, THIS TYPE OF EVENT IS CONSIDERED TO BE A REPORTABLE EVENT CLASSIFIED AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7193 VALVE HAKIM PROGRAMMABLE SANS SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, MEDOS CMPB54

    Patients

    Seq Age Sex Outcome Treatment
    1