BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3614859 · Received February 8, 2014

    Report

    Report Number
    2182208-2014-00244
    Event Type
    Injury
    Date Received
    February 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    November 18, 2013
    Manufacturer
    RICE CREEK MGG
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT PRODUCTS: REDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2013, EXPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN APPROXIMATELY TWO MONTHS OF IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH THRESHOLD. THE RV LEAD WAS EXPLANTED AND REPLACED. DURING THE LEAD REPLACEMENT, WHEN THE NEW RV LEAD WAS CONNECTED TO THE DEVICE IT DID NOT PACE THE HEART IN UNIPOLAR OR BIPOLAR. THE LEAD WAS CHECKED AGAIN WITH THE ANALYZER AND SHOWED GOOD MEASUREMENTS. THE DEVICE WAS ALSO 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
    82329 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MGG 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5076 IMPLANTABLE PACING LEAD