BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2812085 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01834
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 12, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. VENTRICLE OUTPUT CONNECTOR IS OUT OF SPECIFICATION. UPPER AND LOWER CASES ARE CONTAMINATED AND BROKEN. BATTERY RELEASE, LEAD FLEX COVER, SEVEN CASE SCREWS, RING COVER SCREW, BATTERY DRAWER, HEART BLOCK, HEART WIRE CONTACTS, KEYBOARD PAD, HEART LEAD FLEX, BATTERY FLEX, AND RING COVER ARE CONTAMINATED. TWO SIDE BAIL COVERS ARE BROKEN. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. TWO SIDE BAILS ARE CONTAMINATED/MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEART WIRE CONNECTOR BLOCK CONTACTS ON THE VENTRICULAR SIDE OF THE EXTERNAL PULSE GENERATOR DID NOT GRASP FIRMLY, AND WOULD NOT HOLD THE CABLE. THE GENERATOR WAS RETURNED FOR SERVICE AND MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH 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