BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 2201854 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11211
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT WHEN THE LEAD WAS ATTACHED TO THE GENERATOR AND THE SET SCREW WAS TIGHTENED, SOME PAUSES WERE NOTED IN PACING. WHEN THE LEAD WAS ATTACHED TO THE ANALYZER THE PACING WAS CONSISTENT. THE LEAD WAS NOTED TO HAVE NO SIGNS OF DAMAGE BUT LOW IMPEDANCE WAS PRESENT. A NEW DEVICE WAS IMPLANTED, AND THE EXISTING LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR