BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 12243470 · Received July 28, 2021

    Report

    Report Number
    2124215-2021-21876
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    November 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS NOT BEEN RETURNED, THEREFORE TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITIVELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 · 0

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE IS SUSPECTED OF HAVING A PREMATURE BATTERY DEPLETION. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION RECEIVED INDICATES THAT THE SERIAL NUMBER ORIGINALLY REPORTED WAS INCORRECT. IT WAS ORIGINALLY REPORTED AGAINST AN L331-772129 BUT THE CORRECT DEVICE IS L331-772159. THIS DEVICE HAS SINCE BEEN EXPLANTED. AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED. ONCE THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED, THEREFORE TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITIVELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE IS SUSPECTED OF HAVING A PREMATURE BATTERY DEPLETION. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139084 ACCOLADE MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 772159 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R