BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 3861246 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07338
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K843707
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT MEDICAL PRODUCTS: 5068-58 LEAD, (B)(6) 2000. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- A PROXIMAL PORTION WAS RECEIVED MEASURING 6 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. A VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD SHOWED OVERSENSING WITH SUB MUSCULAR POCKET PALPATION. IT WAS NOTED THERE MAY BE LEAD INSULATION FAILURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PIN PORTION OF THE LEAD WAS CUT AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339311 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 6957J

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R SEDR01 IPG