BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790401 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01639
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 31, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. ONE BATTERY CONTACT IS CORRODED / CONTAMINATED AND ONE BATTERY CONTACT IS BROKEN / MISSING. UPPER CASE, BATTERY RELEASE, RING COVER, RELEASE SPRING, BATTERY DRAWER, LCD (LIQUID CRYSTAL DISPLAY), MAIN PRINTED CIRCUIT BOARD, AND ONE CASE SCREW ARE CONTAMINATED. LOWER CASE AND ONE SIDE BAIL COVER ARE BROKEN. ONE SIDE BAIL COVER, ONE SIDE BAIL, RING BAIL, AND ONE CASE SCREW ARE MISSING. LEAD FLEX COVER AND BATTERY FLEX ARE CORRODED. KEYBOARD IS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF THE EPG (EXTERNAL PULSE GENERATOR), THE CONTACTS WERE FOUND TO BE SLIGHTLY CORRODED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other