BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3151764 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05628
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 694958, IMPLANTABLE TACHY LEAD, (B)(6) 2005; D334DRG, DEFIBRILLATOR, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THE ALARM AND WAS INSTRUCTED TO DO A REMOTE TRANSMISSION. THE REMOTE TRANSMISSION SHOWED OVERSENSING, NOISE, HIGH IMPEDANCE AND A POSSIBLE FRACTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS TOLD TO GO TO THE NEAREST EMERGENCY ROOM. THE LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY WHILE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. IT WAS ALSO REPORTED THAT RIGHT ATRIAL (RA) LEAD WAS UNDERSENSING DURING ATRIAL FIBRILLATION AND THE LEAD WAS PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252430 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R