BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 17535550 · Received August 12, 2023

    Report

    Report Number
    MW5142446
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    May 4, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDICAL RECORDS ON 4/25/2011 THAT THIS DEVICE WAS REMOVED DUE TO INFECTION ON (B)(6) 2005. NO OTHER INFORMATION IS KNOWN. 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
    1050795 PULSE GENERATOR, PERMANENT, IMPLANTABLE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC KDR701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown