BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2952359 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00525
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    August 17, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD ON THE DISTAL ELECTRODE, THE HELIX WAS DISTORTED/BENT, THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION, THE OUTER INSULATION HAD ENVIRONMENTAL STRESS CRACKING (ESC), AND THERE WAS APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2009; 305C25 TISSUE VALVE, (B)(6) 2010. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NON-FUNCTIONING WITH ATRIAL-VENTRICULAR DYSSYNCHRONY, AND DID NOT CAPTURE OR SENSE. 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
    56913 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)