BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992594 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09786
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: D224DRG ICD IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED DURING ANOTHER PROCEDURE, AND THAT THERE WAS LOW HIGH-VOLTAGE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) LEAD. IT WAS ALSO REPORTED THAT THE PREVIOUSLY CAPPED ATRIAL LEAD HAD EXPERIENCED A NOISE ISSUE. DURING THE EXPLANT PROCEDURE FOR BOTH ATRIAL LEADS, THE PHYSICIAN DAMAGED THE RV LEAD, SO IT WAS ALSO EXPLANTED, AND THE ATRIAL AND RV LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468838 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R 694575 LEAD