BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREEPI

    MDR report key: 6074422 · Received November 2, 2016

    Report

    Report Number
    2182208-2016-02588
    Event Type
    Death
    Date Received
    November 2, 2016
    Date of Event
    July 1, 2006
    Report Date
    October 7, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE AGE OF THE PATIENTS IS TWENTY-EIGHT (28) YEARS OF AGE. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION LISTED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿EPICARDIAL PACING: A SINGLE-CENTRE STUDY ON 321 LEADS IN 138 PATIENTS.¿ACTA CARDIOL 2006; 61(3): 343-351. 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

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENT DEATHS IDENTIFIED. THERE WERE ALSO REPORTS OF LEAD FRACTURES, INCREASING AND HIGH THRESHOLDS, LOSS OF CAPTURE, ¿EXCESSIVE TRACTION,¿ SEPSIS, INFECTION, ENDOCARDITIS, SURGICAL CONNECTION OF SPARE LEAD, DIAPHRAGMATIC STIMULATION, EXIT BLOCK OCCURRING, AND ¿IMMINENT STRANGULATION.¿ THERE WAS INTERVENTION TAKEN WHICH INCLUDED REPROGRAMMING, LEAD REPLACEMENT, AND IN SOME INSTANCES, LEAD INACTIVATION, LEAD ABANDONMENT WITH LEAD REPLACEMENT. THE STATUS/LOCATION OF THE LEADS IS UNKNOWN. THERE IS NO ALLEGATION OF LEAD-DEATH RELATEDNESS INDICATED IN THE ARTICLE; HOWEVER, THE LEAD-RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725197 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death| H| L| R