BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1921011 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12356
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 9, 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
    ND, US
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. TESTING REVEALED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD REQUIRED REPOSITIONING 18 DAYS POST IMPLANT DUE TO AN INCREASE IN THRESHOLD. DURING THE PROCEDURE, ABOUT 50 ML OF FLUID WAS NOTED IN THE PACEMAKER POCKET. CULTURE WAS OBTAINED AND GRAM STAIN REVEALED GRAM POSITIVE RODS. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 85 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD