BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953298 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00301
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 2, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P920003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NURSE CHANGED THE SETTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE LOW BATTERY LIGHT WAS "BLINKING." THE NURSE TRIED TO CHANGE THE BATTERY AND NOTICED THAT THE BATTERY "TURNED OFF." THE PATIENT WAS NOT PACER-DEPENDENT. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. THE STATUS OF THE EPG IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57196 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5348XW

    Patients

    Seq Age Sex Outcome Treatment
    1