BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1072255 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03895
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    INVALID DATA

    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: NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. OTHER: IT WAS REPORTED THERE WAS A PERFORATION. THERE WAS AN IMPEDANCE DECREASE, TO 400 OHMS, AND NO CAPTURE NOTED AT 7.5 VOLTS, 1 MS. A CHEST X-RAY SHOWED FORWARD PROGRESSION OF THE LEAD. THE LEAD WAS REPLACED. AT EXPLANT, THERE WAS A PROBLEM WITH THE HELIX, AND MANUAL ROTATION WAS REQUIRED. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED STATING THAT THE PATIENT WAS ASYMPTOMATIC, AND THE PERFORATION OCCURRED AT IMPLANT. THE PATIENT IS REPORTED TO BE DOING WELL, AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CAPTURE, FAILURE TO, DISLODGED, IMPEDANCE, LOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PERFORATION. THERE WAS AN IMPEDANCE DECREASE, TO 400 OHMS, AND NO CAPTURE NOTED AT 7.5 VOLTS, 1 MS. A CHEST X-RAY SHOWED FORWARD PROGRESSION OF THE LEAD. THE LEAD WAS REPLACED. AT EXPLANT, THERE WAS A PROBLEM WITH THE HELIX, AND MANUAL ROTATION WAS REQUIRED. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED STATING THAT THE PATIENT WAS ASYMPTOMATIC, AND THE PERFORATION OCCURRED AT IMPLANT. THE PATIENT IS REPORTED TO BE DOING WELL, AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PULSE GENERATOR