BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2813400 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01909
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 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
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS FOUND THAT A CAPACITOR COMPONENT FAILURE CAUSED THE BATTERY REMOVAL TEST FAILURE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT REGARDING NO CAPTURE. HOWEVER, IT WAS CONFIRMED THAT THE CASE WAS DAMAGED. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASE HALVES WERE BROKEN, THE SIDE BAIL COVERS AND BATTERY DRAWER WERE BROKEN, THE RING COVER WAS THE INCORRECT PART, THE BATTERY CONTACTS WERE COMPRESSED, THE SIDE BAILS WERE MISSING, THE KEYBOARD WAS SCRATCHED AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HOSPITAL STAFF, TO THE BIOMEDICAL ENGINEER (BIOMED), THAT THE EPG (EXTERNAL PULSE GENERATOR) WOULD NOT CAPTURE. THE BIOMED ALSO NOTED THERE WAS CASE DAMAGE. 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 HOSPITAL STAFF, TO THE BIOMEDICAL ENGINEER (BIOMED), THAT THE EPG (EXTERNAL PULSE GENERATOR) WOULD NOT CAPTURE. THE BIOMED ALSO NOTED THERE WAS CASE DAMAGE. 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 THE BIOMED THAT STAFF SAID THE DEVICE WOULD NOT CAPTURE. IT WAS NOTED BY THE BIOMED THAT THE CASE OF THE DEVICE IS DAMAGED. THE DEVICE IS BEING 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
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other