BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 14176330 · Received April 21, 2022

    Report

    Report Number
    2124215-2022-07573
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    February 22, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE RETURNED FOR ANALYSIS. UPON RETURN AND ANALYSIS COMPLETION THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS. UPON RETURN AND ANALYSIS COMPLETION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOLLOW UP HIGH PACE IMPEDANCE MEASUREMENTS WERE EXHIBITED ON THIS RIGHT VENTRICULAR (RV) LEAD AS WELL LOSS OF CAPTURE. A REVISION TOOK PLACE AS A RESULT AND A LEAD FRACTURE WAS SEEN, THUS THIS LEAD WAS EXPLANTED AND WILL BE RETURNED. WHEN PLACING A NEW ELECTRODE WITH THIS DEVICE EVIDENCE OF A CORRODED AND OXIDIZED ZONE IN THE AREA OF THE HEADER WAS SEEN, THUS THE DEVICE WAS ALSO REPLACED AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOLLOW UP HIGH PACE IMPEDANCE MEASUREMENTS WERE EXHIBITED ON THIS RIGHT VENTRICULAR (RV) LEAD AS WELL LOSS OF CAPTURE. A REVISION TOOK PLACE AS A RESULT AND A LEAD FRACTURE WAS SEEN, THUS THIS LEAD WAS EXPLANTED AND WILL BE RETURNED. WHEN PLACING A NEW ELECTRODE WITH THIS DEVICE EVIDENCE OF A CORRODED AND OXIDIZED ZONE IN THE AREA OF THE HEADER WAS SEEN, THUS THE DEVICE WAS ALSO REPLACED AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOLLOW UP HIGH PACE IMPEDANCE MEASUREMENTS WERE EXHIBITED ON THIS RIGHT VENTRICULAR (RV) LEAD AS WELL LOSS OF CAPTURE. A REVISION TOOK PLACE AS A RESULT AND A LEAD FRACTURE WAS SEEN, THUS THIS LEAD WAS EXPLANTED AND WILL BE RETURNED. WHEN PLACING A NEW ELECTRODE WITH THIS DEVICE EVIDENCE OF A CORRODED AND OXIDIZED ZONE IN THE AREA OF THE HEADER WAS SEEN, THUS THE DEVICE WAS ALSO REPLACED AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION NOTED THAT THERE WAS NO ISSUE WITH DEVICE L331/923437 AND THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION REGARDING DEVICE L331/924236 CAN BE REVIEWED IN REPORT 14937485.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657729 ACCOLADE MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 924236

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H