BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2122560 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07888
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PLACEMENT OF A TRANSCATHETER HEART VALVE, THE RIGHT VENTRICULAR LEAD WAS DETACHED. THIS OCCURRED WHILE REMOVING A SIZING BALLOON FROM THE PATIENT OVER A GUIDEWIRE. MEDICAL INTERVENTION WAS NEEDED TO SUPPORT THE PATIENT'S RHYTHM (ATROPINE, ATRIAL PACING) AND THE PATIENT REMAINED STABLE. THE PATIENT REMAINED INTUBATED OVERNIGHT. THE LEAD WAS EXPLANTED AND REPLACED THE NEXT MORNING AFTER ANTICOAGULATION WAS COMPLETELY REVERSED. 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 33 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD