BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3152946 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05750
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2008; VEDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY HAD BEEN TOLD THEIR DEVICE HAD THEM "SET TOO HIGH AND IS USING THE BATTERY QUICKLY" AND THE PATIENT WAS CONCERNED SINCE THEY HAD BEEN TOLD THE DEVICE WOULD LAST LONGER. IT WAS ALSO INDICATED THE PATIENT HAD NOT HAD THE DEVICE CHECKED FOR ALMOST THREE YEARS AFTER IMPLANT AND WHEN RECENTLY INTERROGATED AT FOLLOW UP, THE RIGHT ATRIAL (RA) LEAD HAD A HIGH THRESHOLD. THE DEVICE AND RA LEAD REMAIN IN USE. IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALSO HAD A VERY HIGH THRESHOLD. THE HIGH THRESHOLD OF THE RA AND RV LEADS WERE POSSIBLY DUE TO EXIT BLOCK. IT WAS ALSO REPORTED THAT THE LEADS HAD POSSIBLE CORROSION. THE DEVICE WAS EXPLANTED AND REPLACED. 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
    258227 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R