BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE DX

    MDR report key: 7556818 · Received May 31, 2018

    Report

    Report Number
    3010078417-2018-00008
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    March 6, 2017
    Report Date
    May 31, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NUH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME: PATIENT TREATED WITH STENT IMPLANT, RECOVERING AT HOME FOLLOWING HOSPITAL DISCHARGE 5 DAYS AFTER THE INCIDENT. PATIENT CORRECTIVE ACTION: PATIENT HAS DISCONTINUED USE OF THE DEVICE. MANUFACTURER'S PRELIMINARY ANALYSIS: DEVICE HAS BEEN RETURNED FOR TESTING AND WAS FOUND TO BE OPERATING WITHIN INTENDED SPECIFICATION. INITIAL CORRECTIVE ACTION: DEVICE RETURNED FOR INVESTIGATION. FURTHER INFORMATION REQUESTED TO ENABLE THOROUGH INVESTIGATION AND MEDICAL OPINION TO BE SOUGHT.

    Description of Event or Problem · 1

    CUSTOMER PURCHASED THE DEVICE (B)(6) 2017 FOR DIABETIC NEUROPATHY. USED THE DEVICE FOR THE 2ND TIME ON (B)(6) 2017, SETTINGS UNKNOWN. ON THE MORNING OF (B)(6) 2017, JR SUFFERED A HEART ATTACK AND WAS HOSPITALISED. TREATMENT INCLUDED STENT IMPLANT, SPECIFIC LOCATION OF STENT UNKNOWN. (B)(6) DISCHARGED FROM HOSPITAL (B)(6) 2017. RECOVERING WELL AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401584 REVITIVE DX CIRCULATION BOOSTER NUH ACTEGY LTD REVITIVE DX

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization