BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152113 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01179
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF ELECTRICAL SPECIFICATION (SEGMENTS MISSING). ANALYSIS ALSO FOUND THE RING COVER AND TWO SIDE BAIL COVERS ARE BROKEN. BATTERY CONTACTS COMPRESSED. ONE SIDE BAIL AND RING ARE MISSING. KEYBOARD PAD IS CONTAMINATED AND HAS A COSMETIC ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED SOME LINES ON MENU SCREEN ARE MISSING. IT WAS ALSO REPORTED THE SCREEN ICON SUGGESTED BREAKAGE. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252452 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5388X

    Patients

    Seq Age Sex Outcome Treatment
    1