BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 6630968 · Received June 9, 2017

    Report

    Report Number
    2649622-2017-07524
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 4, 2017
    Report Date
    December 6, 2017
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4068-45 LEAD, IMPLANTED (B)(6) 2000-07-11; 8042B IPG, IMPLANTED (B)(6) 2007.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A RIGHT VENTRICULAR (RV) LEAD WARNING FOR LOW IMPEDANCE. IT WAS ALSO NOTED THE RV LEAD IMPEDANCE HAD DECREASED. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN A PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS 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
    413019 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 4968-35 LEAD, (B)(4)