BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791463 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01722
    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 ELECTRICAL SPECIFICATION; DIODE ON THE VENTRICLE OUTPUT IS SHORTED. UPPER CASE IS DAMAGED AND BROKEN. LOWER CASE IS DAMAGED (NOT ENOUGH CASE TO PUT NEW CONTACTS IN). BOTH BAIL COVERS, ONE CASE SCREW, AND BOTH BAILS ARE MISSING. THE RING IS BENT. KEYBOARD WINDOW IS SCRATCHED. IT IS NOTED THERE IS DAMAGE DUE TO A NON MEDTRONIC PERSON DISASSEMBLING AND REASSEMBLING THE DEVICE; APPEARS LOWER CASE WAS REPLACED; MAIN SEAL IS NOT RTV (ROOM TEMPERATURE VULCANIZING) SEALED INTO LOWER CASE AND IS BROKEN; PCB (PRINTED CIRCUIT BOARD) FLEXES ON MAIN PCB ARE INSERTED INTO CONNECTION ALL THE WAY AND ONE IS NOT FULLY CLOSED; PCB SCREW ON HEART LEAD FLEX IS IN PLACE BUT NOT TIGHTEN DOWN; SERIAL NUMBER LABEL IS DAMAGED (LABEL HAS BEEN TRIMMED AND PLACED ON THE CASE); BATTERY CONTACTS ARE DAMAGED (BENT) AND POSITIVE CONTACT TO FLEX IS BENT UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD INCORRECT OUTPUTS. THE GENERATOR 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