BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952287 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00099
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. ANALYSIS DID FIND THAT THE LOWER CASE WAS BROKEN, BOTH BAIL COVERS WERE BROKEN AND CONTAMINATED, THE RING COVER WAS CONTAMINATED, ONE CASE SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT AND THE HEART LEAD FLEX WAS OUT OF SPECIFICATION. FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX. THIS ANALYSIS FOUND THAT THE FLEX FAILURE OF IMPROPERLY CONDUCTING VENTRICULAR-RELATED SIGNALS WAS RELATED TO A DIODE COMPONENT ON THE FLEX ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER FOUND THAT THE LOWER DISPLAY WAS VERY DIM AND DIFFICULT TO READ. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57074 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1