BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953334 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00312
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 14, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; CASE HALVES AND WHEEL ASSEMBLIES ARE BROKEN OFF AND MISSING. CABLE IS TWISTED APPROXIMATELY 19 INCHES FROM HEART WIRE CONNECTOR AND APPROXIMATELY 28 INCHES FROM EPG (EXTERNAL PULSE GENERATOR) PLUG. CABLE CONTINUITY TESTS OK. NO INTERMITTENT CONNECTION FOUND WHEN CABLE IS BENT /MANIPULATED. CONNECTIONS WERE NOT SHORTING OUT BETWEEN THEMSELVES.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CABLES WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) CABLES WERE "BROKEN." OF NOTE, THE PLASTIC SCREW KNOB SHOWED "PHYSICAL BREAKAGE." THE HOSPITAL HAD RECENTLY REVISED THEIR CLEANING/STERILIZATION PROCESS AND NOTED THE CABLES WERE "BREAKING" FOLLOWING THE STERILIZATION PROCESS. THE CABLES WILL BE RETURNED. NO PATIENT INVOLVEMENT OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56886 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5433AL 0815

    Patients

    Seq Age Sex Outcome Treatment
    1