BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953720 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01342
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT HELIX WAS BENT, THE DISTAL END LOW VOLTAGE ELECTRODE HAD BLOOD AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX BENT. DUE TO THE BENT HELIX, THE HELIX EXTENSION/RETRACTION/LENGTH TESTING COULD NOT BE PERFORMED.

    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: 5092, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    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 THAT THE RIGHT ATRIAL (RA) LEAD HAD POOR SENSING ONE MONTH POST IMPLANT. REPOSITIONING WAS ATTEMPTED BUT UNSUCCESSFUL, SO THE LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED HEART SURGERY IN THE PAST AND HAD NO ATRIAL APPENDAGE, AND THE PHYSICIAN FELT THE LEAD WAS HARD TO REPOSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56394 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R VEDR01 IMPLANTABLE PULSE GENERATOR