BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1792345 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07081
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 ALERT WAS TRIGGERED FOR LOW IMPEDANCE OF LESS THAN 200 OHMS FOR THE RIGHT ATIAL (RA) LEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION, AND THE DEVICE WAS PROGRAMMED VVIR. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THE RA LEAD WAS CAPPED AND NOT REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD CHRONICALLY HIGH THRESHOLD AND WAS CAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED FOR LOW IMPEDANCE OF LESS THAN 200 OHMS FOR THE RIGHT ATIAL (RA) LEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION, AND THE DEVICE WAS PROGRAMMED VVIR. IT WAS FURTHER REPORTED THE RA LEAD WAS CAPPED AND NOT REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD CHRONICALLY HIGH THRESHOLD AND WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED FOR LOW IMPEDANCE OF LESS THAN 200 OHMS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION, AND THE DEVICE WAS PROGRAMMED VVIR. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O| R 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB