BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 3150601 · Received June 6, 2013

    Report

    Report Number
    1226348-2013-18313
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 15, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    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 IT WAS NOTED THE VALVE WAS VISUALLY INSPECTED AND CONFIRMED THE TEAR IN THE SILICONE HOUSING. ALTHOUGH IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE TEAR IN THE HOUSING, IT MIGHT BE POSSIBLE THAT THE DEVICE CAME IN CONTACT WITH A SHARP OR POINTED OBJECT DURING THE IMPLANT OR EXPLANTS OF THE DEVICE, THIS HOWEVER COULD NOT BE DETERMINED. IT WAS ALSO NOTED THAT THE CATHETER WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. THE LOT RECORDS COULD NOT BE REVIEWED FOR THE CATHETER AS THE LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE WARNS HEALTH CARE USERS TO USE EXTREME CARE WHEN HANDLING SILICONE PRODUCTS AS SILICONE HAS A LOW TEAR RESISTANCE. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. WE DO NOT USE THERAPY DATES. AS A RESULT, TODAY'S DATE WAS USED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT AFTER IMPLANTATION, FLUID ACCUMULATION WAS NOTED. THE DEVICE WAS REPLACED DUE TO SILICONE HOUSING BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251437 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM, & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)