BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

    MDR report key: 17516853 · Received August 11, 2023

    Report

    Report Number
    MW5123802
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    July 16, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    LWP
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT ON (B)(6) 2018 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC LEADS EXPLANTED DUE TO HIGH IMPEDANCES. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244104 IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown