BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2953224 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00294
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 15, 2007
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4) IMPLANTABLE PULSE GENERATOR, (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT THE PATIENT WAS FOUND TO HAVE A PNEUMOTHORAX. THIS REQUIRED CHEST TUBE DRAINAGE AND PROLONGED HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55761 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R 4574 IMPLANTABLE PACING LEAD