BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 2954739 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02394
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 5568, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PHYSICIAN INDICATED THE PATIENT HAD A "DEFECTIVE WIRE" BUT DID NOT INDICATE WHICH LEAD. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PHYSICAN INDICATED THE PATIENT HAD A "DEFECTIVE WIRE" BUT DID NOT INDICATE WHICH LEAD. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT HAD A RIGHT VENTRICULAR (RV) LEAD REVISION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58891 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR (B)(4)