BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 11104351 · Received January 2, 2021

    Report

    Report Number
    2124215-2020-25645
    Event Type
    Injury
    Date Received
    January 2, 2021
    Date of Event
    November 3, 2020
    Report Date
    June 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604522
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS, SHOULD PERTINENT INFORMATION BE PROVIDED. PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF SURGERY. 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 INSULATION INTEGRITY. MEASUREMENTS 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 OF LOSS OF CAPTURE, HIGH CAPTURE THRESHOLDS AND DISLODGEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE INDICATES THAT THIS LEAD EXHIBITED LOSS OF CAPTURE AND HIGH CAPTURE THRESHOLDS DUE TO SUSPECTED MICRO-DISLODGEMENT. ALSO, THE MICRO-DISLODGEMENT IS SUSPECTED AS THERE WAS NO EVIDENCE OF EFFUSION ON THE ECHOCARDIOGRAM AND THE X-RAY WAS SIMILAR THAN AT IMPLANT. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS, SHOULD PERTINENT INFORMATION BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE INDICATES THAT THIS LEAD EXHIBITED LOSS OF CAPTURE AND HIGH CAPTURE THRESHOLDS DUE TO SUSPECTED MICRO-DISLODGEMENT. ALSO, THE MICRO-DISLODGEMENT IS SUSPECTED AS THERE WAS NO EVIDENCE OF EFFUSION ON THE ECHOCARDIOGRAM AND THE X-RAY WAS SIMILAR THAN AT IMPLANT. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1022002 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R