BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1922214 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12803
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, HOWEVER THE PROXIMAL CONDUCTOR WAS DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); THE OUTER INSULATION WAS BREACHED CUT; AND THERE WAS APPARENT EXPLANT DAMAGE. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD DISLODGED. THE LEAD WAS REMOVED AND REPLACED. 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 SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other