BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 1990951 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00137
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE RIGHT ATRIAL LEAD HAD HIGH THRESHOLD AND A LEAD WARNING WAS TRIGGERED. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EPICARDIAL ATRIAL LEAD IMPEDANCE IS VARYING FROM 600 OHMS TO GREATER THAN 2500 OHMS. IT WAS ALSO REPORTED THAT WITH ISOMETRICS, THERE IS NOISE ON THE ATRIAL ELECTROGRAM. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R 6948 IMPLANTABLE TACHY LEAD| 4968 IMPLANTABLE PACING LEAD