BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1922533 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12991
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN POSITIONED THE FIRST LEAD OF A PROCEDURE ON THE LEFT SIDE OF THE HEART. A SECOND LEAD DID NOT PROPERLY IMPLANT, SO THE PHYSICIAN TRIED A MEDTRONIC RIGHT ATRIAL LEAD WHICH ALSO DID NOT PROPERLY IMPLANT AFTER MULTIPLE ATTEMPTS. THE MEDTRONIC LEAD WAS NOT USED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A STROKE, WHILE THE PHYSICIAN WAS WORKING ON THE LEFT SIDE OF THE HEART. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R