BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152995 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00590
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE GENERATOR WOULD NOT CAPTURE. ANALYSIS DID FIND THE UPPER AND LOWER CASE HALVES, BATTERY RELEASE AND BOTH BAIL COVERS AS WELL AS THE RING COVER WERE BROKEN, THAT THE BATTERY FLEX, HEART LEAD FLEX, HEART BLOCK AND HEART WIRE CONTACTS WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, THE MAIN SEAL, THE ENCODER FLEX AND THE HEART LEAD FLEX WERE DAMAGED, ONE CASE SCREW WAS MISSING AND THE BATTERY CONTACTS WERE COMPRESSED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY STAFF, TO THE BIOMEDICAL ENGINEER, THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT CAPTURE. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY STAFF, TO THE BIOMEDICAL ENGINEER, THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT CAPTURE. THE EPG 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
    254871 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention