BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791447 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01721
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 13, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. OUTPUT FLEX IS OUT OF SPECIFICATION. UPPER AND LOWER CASE HALVES AND BATTERY DRAWER ARE BROKEN. BATTERY CONTACTS ARE COMPRESSED. BOTH BAIL COVERS, RING COVER, THREE CASE SCREWS, RING COVER SCREW, BOTH BAILS, AND RING ARE MISSING. KEYBOARD WINDOW IS SCRATCHED. SERIAL NUMBER LABEL IS DAMAGED. LEAD FLEX COVER IS CORRODED. IT IS NOTED THAT THERE WAS DAMAGE DUE TO A NON MEDTRONIC PERSON DISASSEMBLING AND REASSEMBLING THE DEVICE; NO RTV (ROOM TEMPERATURE VULCANIZING) SEALANT ON ATRIAL CONNECTOR; HEART FLEX PCB (PRINTED CIRCUIT BOARD) CONNECTION WAS PULLED OUT WITHOUT OPENING THE PCB CONNECTOR WHICH DAMAGED THE FLEX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD INCORRECT OUTPUTS. IT WAS RETURNED FOR SERVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    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