BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2813406 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01910
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 19, 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

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE UNIT WOULD NOT CAPTURE, HOWEVER IT DID CONFIRM THE CUSTOMER COMMENT THAT THE UPPER CASE WAS BROKEN AND THE LOWER CASE WAS MELTED. ANALYSIS ALSO FOUND THAT THE BATTERY RELEASE, LEAD FLEX COVER AND BATTERY DRAWER WERE CONTAMINATED, THAT THE BATTERY CONTACTS WERE COMPRESSED, ONE SIDE BAIL AND THE RING WERE MISSING, ONE SIDE BAIL WAS BENT, THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION AND THE KEYBOARD SCRATCHED.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS CONFIRMED THE PCB BATTERY REMOVAL TEST FAILURE SEEN DURING REPAIR OF THE DEVICE CAUSED BY A CAPACITOR COMPONENT FAILURE.

    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 DEVICE HAS CASE DAMAGE. THE DEVICE IS BEING 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 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.

    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