BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 3864945 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01787
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. AUTO LEAD DIAGNOSTICS SHOWS A HIGH COUNT OF OPEN CIRCUIT PACES WITH AN RV LEAD WARNING ON (B)(6) 2014. LEAD TREND SHOWED IMPEDANCE OUT OF RANGE (OOR) HIGH.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHEN CHECKING THEIR PULSE, HEART RATE WAS FOUND TO BE BETWEEN 40 AND 50 BEATS PER MINUTE. UPON INTERROGATION, A LEAD IMPEDANCE OF GREATER THAN 9,999 OHMS WAS MEASURED, AND A PACING FAILURE WAS OBSERVED. LEAD FRACTURE WAS SUSPECTED, HOWEVER, WAS NOT CONFIRMED AFTER THE PATIENT'S CHEST X-RAY. THE LEAD WAS CAPPED 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
    339530 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4951M-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Hospitalization| R ADSR01 IPG