BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE REPORTING PROCESSOR (CHIRP)

    MDR report key: 15893877 · Received November 30, 2022

    Report

    Report Number
    MW5113553
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 11, 2022
    Report Date
    November 28, 2022
    Manufacturer
    CANARY MEDICAL USA, LLC.
    Product Code
    QPP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A MEDICAL DEVICE MANUFACTURED BY CANARY MEDICAL ((B)(6) BASED) WAS IMPLANTED IN MY LEFT KNEE UPON TOTAL LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2022. THE DEVICE IS SUPPOSE TO TRANSMIT NEEDED MEDICAL DATA TO MY DOCTOR. IT DOES NOT TRANSMIT. IT IS DEFECTIVE. THIS DATA IS CRUCIAL FOR MY RECOVERY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348874 IMPLANTABLE REPORTING PROCESSOR (CHIRP) IMPLANTABLE POST-SURGICAL KINEMATIC MEASUREMENT KNEE DEVICE QPP CANARY MEDICAL USA, LLC. 13193

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other LISINOPRIL| PACEMAKER