BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951865 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00071
    Event Type
    Injury
    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/S72
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CORRECTION: PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE WAS DENTED, THE LOWER CASE AND BATTERY DRAWER WERE BROKEN, THE SIDE BAIL COVERS WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, AND THE KEYBOARD WAS SCRATCHED. FURTHER ANALYSIS WAS PERFORMED ON THE PCB. THIS ANALYSIS FOUND THAT A CAPACITOR COMPONENT ON THE PCB CAUSED THE BATTERY REMOVAL TEST FAILURE. CONCLUSION: CONFIRMED FAILURE MODE CAUSED BY THE CAPACITOR FAILURE. (B)(4).

    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 THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER FOUND THAT THE DEVICE WOULD IMMEDIATELY SHUT OFF WHEN THE BATTERY DRAWER WAS OPENED DESPITE REPLACING THE BATTERY. THEREFORE, 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 THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER FOUND THAT THE DEVICE WOULD IMMEDIATELY SHUT OFF WHEN THE BATTERY DRAWER WAS OPENED DESPITE REPLACING THE BATTERY. THEREFORE, 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
    55746 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention