BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRAFLEX

    MDR report key: 4162682 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03066
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    April 1, 2013
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED AND ANALYZED. ANALYSIS OF THE DATE INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED. AVERAGE VENTRICULAR THRESHOLD IS ELEVATED AND VARIABLE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: ADDR01, IPG, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED DUE TO UNEXPECTED LONGEVITY. ELEVATED THRESHOLDS WERE OBSERVED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WHICH REMAIN 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
    644628 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4951M-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR 4951M-35 LEAD