BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 8805090 · Received July 18, 2019

    Report

    Report Number
    2124215-2019-13891
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    April 22, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523489
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT OF THIS INGEVITY LEAD, THE PHYSICIAN REPORTED TORTUOUS AND NARROW ANATOMY; HOWEVER THE LEAD WAS IMPLANTED AND THE PROCEDURE COMPLETED. TWO DAYS LATER, HIGH PACING THRESHOLDS WERE OBSERVED IN SPITE OF ALL OTHER MEASUREMENTS BEING REPORTED AS NORMAL. AN X-RAY WAS TAKEN TO ASSESS THE LEAD POSITION; NO CHANGES FROM IMPLANT IMAGES WERE OBSERVED. THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE AND REPOSITION THE LEAD AS AN ATTEMPT TO OBTAIN BETTER PACING THRESHOLDS. THREE DAYS POST THE REVISION PROCEDURE. A FOLLOW-UP ONCE AGAIN EXHIBITED HIGH PACING THRESHOLDS AND THE X-RAY TAKEN AT THIS TIME, DID CONFIRM A LEAD POSITION CHANGE AND A PERFORATION. ANOTHER REVISION WAS MADE AND THE LEAD ABANDONED; A NON BOSTON SCIENTIFIC PRODUCT WAS THEN IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED DUE TO THE REPORTED PERFORATION. SUBSEQUENTLY, THE PREVIOUSLY REPORTED ABANDONED LEAD WAS RECEIVED FOR ANALYSIS. THE RETURNED LEAD WAS EVALUATED AS PER THE NORMAL RETURNED PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF THIS INGEVITY LEAD, THE PHYSICIAN REPORTED TORTUOUS AND NARROW ANATOMY; HOWEVER THE LEAD WAS IMPLANTED AND THE PROCEDURE COMPLETED. TWO DAYS LATER, HIGH PACING THRESHOLDS WERE OBSERVED IN SPITE OF ALL OTHER MEASUREMENTS BEING REPORTED AS NORMAL. AN X-RAY WAS TAKEN TO ASSESS THE LEAD POSITION; NO CHANGES FROM IMPLANT IMAGES WERE OBSERVED. THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE AND REPOSITION THE LEAD AS AN ATTEMPT TO OBTAIN BETTER PACING THRESHOLDS. THREE DAYS POST THE REVISION PROCEDURE. A FOLLOW-UP ONCE AGAIN EXHIBITED HIGH PACING THRESHOLDS AND THE X-RAY TAKEN AT THIS TIME, DID CONFIRM A LEAD POSITION CHANGE AND A PERFORATION. ANOTHER REVISION WAS MADE AND THE LEAD ABANDONED; A NON BOSTON SCIENTIFIC PRODUCT WAS THEN IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED DUE TO THE REPORTED PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598048 INGEVITY MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7742 884802 00802526523489

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening