BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951688 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00058
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOMEDICAL DEPARTMENT RECEIVED AN EXTERNAL PULSE GENERATOR (EPG) THAT WAS NOT CAPTURING. THE BIOMEDICAL ENGINEER STATED THAT RECENTLY THEY STARTED USING DISPOSABLE WIRES FROM REMINGTON AND THIS CAPTURE ISSUE HAD BEEN REPORTED "SEVERAL TIMES SINCE." TECHNICAL SERVICES SUGGESTED THAT THE DISPOSABLE CABLES BE USED TO SEE IF THE ISSUE IS WITH THE CABLES. FURTHER INVESTIGATION WILL BE CONDUCTED BY THE CALLER. ANOTHER EPG WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57116 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R