BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1991345 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02363
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 23, 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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. NO ANOMALIES WERE FOUND.

    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 PATIENT SENT A REMOTE TRANSMISSION FOLLOWING A FALL. THE TRANSMISSION INDICATES LOSS OF CAPTURE AND SENSING IN THE ATRIUM. LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD THRESHOLD "JUMPED" AND THAT THE LEAD WAS CAPPED AND REPLACED.

    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 45 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD