BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1792327 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07071
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 THE PATIENT WAS IN ATRIAL PACED VENTRICULAR PACED (AP-VP) RHYTHM AT 60PPM. DURING A SENSING TEST, THE PATIENT HAD AN UNDERLYING RATE AROUND 50 PPM, WITH THE AS AND VS MARKERS 20-30 MS APART. NO DEFLECTION COULD BE SEEN ON SURFACE ECG AFTER AN ATRIAL PACE, EVEN AT HIGH OUTPUTS, DURING A THRESHOLD TEST. ATRIAL CAPTURE WAS QUESTIONED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO 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 67 YR Required Intervention (B)(4) CRDM NON-DEFIB LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR