BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952428 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00112
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE PASSED TESTING, WITH NO ANOMALIES FOUND. THE LOWER CASE WAS OBSERVED TO BE BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAPID ATRIAL PACING (RAP) AND THE OUTPUT FOR THE EXTERNAL PULSE GENERATOR (EPG) WERE NOT WITHIN SPECIFICATION. THEREFORE, 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 THAT THE RAPID ATRIAL PACING (RAP) AND THE OUTPUT FOR THE EXTERNAL PULSE GENERATOR (EPG) WERE NOT WITHIN SPECIFICATION. THEREFORE, 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
    56672 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTE MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention