BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4132109 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14923
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    August 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    INFORMATION WAS RECEIVED THAT THE LEAD WAS SUCCESSFULLY REPOSITIONED. THERE WAS NO PHRENIC NERVE STIMULATION WITH THE NEW POSITION. ALL MEASUREMENTS WERE APPROPRIATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PHRENIC NERVE STIMULATION, HIGH THRESHOLD MEASUREMENTS AND FLUCTUATING IMPEDANCE MEASUREMENT BETWEEN 900-1600 OHMS. IT WAS CONFIRMED THAT THE RV LEAD HAD MISTAKENLY BEEN IMPLANTED IN THE CORONARY SINUS. PROGRAMMING WAS ADJUSTED TO ENSURE ADEQUATE THERAPY WAS PROVIDED WITHOUT CREATED PHRENIC NERVE STIMULATION. AS A RESULT OF THIS PROGRAMMING CHALLENGE, THE STANDARD SAFETY MARGIN WAS NOT POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610650 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7742| 7741| J176