BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4131498 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13804
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE IMPLANTED WITH A COMPETITOR DEVICE. UPON INITIAL TESTING AT IMPLANT, PACE IMPEDANCE, THRESHOLD, AND SENSING MEASUREMENTS WERE WITHIN NORMAL LIMITS. DURING PRE-DISCHARGE TESTING, IT WAS NOTED THAT PACE IMPEDANCES WERE GREATER THAN 9,999 OHMS AND LOSS OF CAPTURE (LOC) WAS OBSERVED. A REVISION PROCEDURE WAS PERFORMED WHEREIN IT WAS DISCOVERED THE LEADS HAD NOT BEEN PROPERLY INSERTED INTO THE CONNECTOR BLOCK OF THE DEVICE. THE LEADS WERE REINSERTED AND THE PROCEDURE CONCLUDED WITHOUT CONSEQUENCE. THE PATIENT WAS LATER DISCHARGED TO HOME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610625 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7732

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7732| 7741| MISMATCH