BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153184 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05851
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE 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. PRODUCT: P1501DR IMPLANTABLE PULSE GENERATOR (B)(6) 2008; 5076 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS HAD EPISODES THAT LOOKED LIKE FAR-FIELD OVERSENSING AND NOISE. THE OVERSENSING WAS CAUSING PACING INHIBITION. THE EVENTS SHOWED "MIRROR IMAGE" ELECTROGRAMS AND IT WAS SUSPECTED THERE WAS OUTER INSULATION DAMAGE TO BOTH LEADS. ALSO, THERE WAS AN AREA ON THE CHEST X-RAY WHERE THE LEADS APPEARED TO BE CONSTRICTED. THE RA AND RV LEADS WERE BOTH CAPPED 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
    254852 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R