BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3862512 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06868
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    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: 5076-52 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF THE ATRIAL, PACED MORPHOLOGY WAS NOTED TO BE FLIPPING RANDOMLY BETWEEN POSITIVE AND NEGATIVE. INTERROGATION OF THE DEVICE SHOWED THAT THE ATRIAL LEAD WAS SENSING BOTH ATRIUM AND VENTRICLE. THE LEAD WAS EXPLANTED 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
    339485 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R ADDRL1 IPG