BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 3991758 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07962
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 29, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. 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 PRODUCT: 7278 ICD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD AN IMPEDANCE JUMP AND WAS FOUND TO BE HIGH. THE LEAD ALSO HAS A POSSIBLE FRACTURE. THE LEAD WAS CAPPED AND REPLACED. 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 REMOVED WITH LASER WHEN THE SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THERE WAS NOISE AND HIGH SHORT INTERVAL COUNTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472182 CAPSUREFIX NOVUS MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R 6947 LEAD