BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 11104262 · Received January 2, 2021

    Report

    Report Number
    2124215-2020-26046
    Event Type
    Injury
    Date Received
    January 2, 2021
    Date of Event
    October 27, 2020
    Report Date
    February 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523397
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE FOLLOWING CODES WERE ADDED IN H6 (DEVICE CODES) AS THEY WERE MISSED FROM PREVIOUS REPORTS: SIGNAL ARTIFACT - A090801 OVERSENSING - A070909 PACING PROBLEM - A0712 B5 (PROBLEM DESCRIPTION) WAS UPDATED AS NEW CODES WERE ADDED TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF SURGERY. CORRECTED FIELDS: H6 (EVALUATION CONCLUSION CODE) CODE WAS UPDATE TO "KNOWN INHERENT RISK OF DEVICE". B5 (PROBLEM DESCRIPTION) WAS UPDATED WITH BETTER VERBIAGE AND ORTHOGRAPHY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD EXHIBITED IMPEDANCE ISSUES, HIGH PACING THRESHOLDS MEASUREMENTS, LOSS OF CAPTURE, NOISE, OVERSENSING AND PACING INHIBITION. THROUGH FLUOROSCOPY AND X-RAYS, IT WAS CONFIRMED THAT THIS LEAD HAD A CONDUCTOR FRACTURE AND INSULATION DAMAGE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD EXHIBITED IMPEDANCE ISSUES, HIGH PACING THRESHOLDS MEASUREMENTS AND LOSS OF CAPTURE. THROUGH FLUOROSCOPY AND X-RAYS, IT WAS CONFIRMED THAT THIS LEAD HAD A CONDUCTOR FRACTURE AND INSULATION DAMAGE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED IMPEDANCE ISSUES, HIGH PACING THRESHOLDS MEASUREMENTS AND LOSS OF CAPTURE. THROUGH A FLUOROSCOPY AND X-RAY, IT WAS CONFIRMED THIS LEAD HAD A CONDUCTOR FRACTURE AND INSULATION DAMAGE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7736 670843 00802526523397

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R