BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952283 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00144
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE AMPLITUDE OUTPUT WAS LOWER THAN THE SELECTED LEVEL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE IT WAS DISCOVERED THAT AMPLITUDE OUTPUT WAS SIGNIFICANTLY LOWER THAN THE AMPLITUDE SELECTED ON THE EXTERNAL PULSE GENERATOR. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56326 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MANUFACTURING 5348

    Patients

    Seq Age Sex Outcome Treatment
    1