BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 3864902 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01806
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 1, 2006
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS APPROXIMATELY 60% MALE AND THE BASELINE AGE IS APPROXIMATELY 70 YEARS OLD. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: MULTI-CENTER CLINICAL EXPERIENCE WITH A LUMENLESS, CATHETER-DELIVERED, BIPOLAR, PERMANENT PACEMAKER LEAD: IMPLANT SAFETY AND ELECTRICAL PERFORMANCE. PACE. 2006; VOL 29, P858-865. CONCOMITANT MEDICAL PRODUCTS: 10600, CATHETER. (B)(4).

    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 LEAD/SERIAL NUMBERS. MULTIPLE FAILURE MODES/PATIENT COMPLICATIONS WERE REFERENCED IN THE ARTICLE, WITH NO SPECIFIC LEAD MODEL FAILURE INDICATIONS. THE ATRIAL LEAD FAILURE/PATIENT COMPLICATION MODES WERE NOTED AS: DISLODGEMENT, CARDIAC PERFORATION, FAILURE TO SENSE/UNDERSENSING, AND MICRODISLODGEMENT. THE VENTRICULAR LEAD FAILURE MODES/PATIENT COMPLICATIONS WERE NOTED AS: ELEVATED PACING THRESHOLDS, PERICARDIAL EFFUSION, DISLODGEMENT, FAILURE TO CAPTURE/LOSS OF CAPTURE, CARDIAC PERFORATION, TAMPONADE, AND BRADYCARDIA. THE STATUS OF EACH LEAD IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339420 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| L| R 3830 ATRIAL LEAD