BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1792298 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07064
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    April 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIPOLAR LEAD IMPEDANCE HAD ABRUPTLY INCREASED FROM 506OHMS TO 1100OHMS ON REMOTE INTERROGATION. IN OFFICE MEASUREMENTS ON SHOWED BIPOLAR IMPEDANCE AT 1331OHMS WITH UNIPOLAR AT 436OHMS. THE LEAD THRESHOLDS BOTH BIPOLAR AND UNIPOLAR HAD INCREASED FROM 0.75V TO 1V AT 0.4MS. SENSING WAS REPORTED AS WITHIN NORMAL LIMITS. OVERSENSING WAS NOT ABLE TO BE FORCED. THE DEVICE WAS REPLACED. THE LEAD REMAINS IN USE. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD