BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3990683 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08524
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WAS SETSCREW DAMAGE ON THE LEAD ADAPTOR. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4)

    Additional Manufacturer Narrative · 1

    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 MEDICAL PRODUCTS: 5071-35 LEAD, IMPLANTED: (B)(6) 2014; 5866-38M ADAPTOR, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIRTY MINUTES POST IMPLANT THE TWO RIGHT VENTRICULAR (RV) LEADS EXHIBITED UNSTABLE THRESHOLDS, NON CAPTURE, NO ISE, LOW AND VARYING IMPEDANCE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. IT WAS NOTED THAT THE LEAD EXTENSION SET-SCREWS WERE DAMAGED DURING INITIAL IMPLANT. THE LEAD EXTENSION WAS NOT EASILY REMOVED AND WAS REQUIRED TO BE CUT OFF FROM THE RV LEADS. A NEW LEAD EXTENSION AND TWO NEW RV LEADS WERE IMPLANTED. AFTER EXPLANT, BIPOLAR RETESTING OF THE RV LEADS STILL SHOWED UNSTABLE IMPEDANCE AND THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471964 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R ADSR01 IPG