BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1791815 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06949
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    June 11, 2008
    Report Date
    March 21, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED IN-PART ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HIS "DAMAGED, FRACTURED AND DEFECTIVE" LEAD WAS REPLACED. ADDITIONAL INFORMATION PROVIDED BY THE HCP INDICATED THE RV LEAD WAS REPLACED DUE TO POOR SENSING, UNACCEPTABLE THRESHOLDS AND HIGH IMPEDANCES. THE HCP WAS ABLE TO RE-USE THE PACE/SENSE PORTION OF THE HIGH VOLTAGE LEAD THAT HAD BEEN PREVIOUSLY CAPPED. THE HCP ALSO INDICATED THE LV LEAD WAS PROGRAMMED OFF DUE TO DISLODGEMENT AND UNACCEPTABLE THRESHOLDS. THE PATIENT HAS SINCE PROVIDED ADDITIONAL INFORMATION INDICATING THAT AFTER THE IMPLANT OF HIS SYSTEM IN 2005. HE HAS HAD MULTIPLE ER VISITS, ONGOING DAMAGES, AND COMPLICATIONS. THE PATIENT HAS REPORTEDLY EXPERIENCED FAINTING, DIZZINESS, A POSSIBLE ANEURYSM OR PULMONARY EMBOLISM, LIGHT-HEADEDNESS, SEIZURES, AND A TOXIC FEELING. THE PATIENT ALSO REPORTED LEAD FRACTURE , INNAPPROPRIATE STIMULATIONS, LEAD FRACTURE AND DEVICE MALFUCTIONS. THE ATRIAL LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 55 YR Male Required Intervention| O 6947 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB