BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2955386 · Received February 11, 2013

    Report

    Report Number
    2183613-2013-00192
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MILACA INC
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE UPPER AND LOWER CASES WERE BROKEN. ANALYSIS ALSO FOUND THE MAIN PRINTED CIRCUIT BOARD TO BE OUT OF SPECIFICATION ELECTRICALLY. THE BATTERY RELEASE, HEART WIRE BLOCK, HEART WIRE LEADS AND LEAD FLEX COVER WERE CONTAMINATED. THE TWO SIDE BAIL COVERS WERE BROKEN AND THE BATTERY CONTACTS WERE COMPRESSED, THE RING AND ONE SIDE BAIL WERE BENT, THE BATTERY DRAWER WAS BROKEN AND THE KEYBOARD HAD COSMETIC DAMAGE. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS FOUND THAT THE PCB WAS NOT OUT OF SPECIFICATION, BUT RATHER NEEDED CALIBRATION. ONCE THE UNIT WAS CALIBRATED, THE MAIN PCB PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT DURING AN INSPECTION OF THE EXTERNAL PULSE GENERATOR (EPG), IT WAS NOTICED THAT THE DEVICE HAD A CRACKED CASE. THE EPG WAS RETURNED FOR REPAIR AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58515 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1