BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 16414805 · Received February 21, 2023

    Report

    Report Number
    2124215-2023-08096
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604577
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. 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 THIS RIGHT VENTRICULAR LEAD GOT DISLODGED SHORTLY AFTER IMPLANT. THE PATIENT EXPERIENCED CHEST PAIN, A MICRO PERFORATION WAS SUSPECTED. IT WAS ALSO NOTED THAT AN X-RAY AND FLUOROSCOPY WERE PERFORMED TO CONFIRM THE DISLODGEMENT AND TO RULE OUT A PERICARDIAL EFFUSION. THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD GOT DISLODGED SHORTLY AFTER IMPLANT. THE PATIENT EXPERIENCED CHEST PAIN, A MICRO PERFORATION WAS SUSPECTED. IT WAS ALSO NOTED THAT AN X-RAY AND FLUOROSCOPY WERE PERFORMED TO CONFIRM THE DISLODGEMENT AND TO RULE OUT A PERICARDIAL EFFUSION. THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385669 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1243327 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H| L