BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACTIV8

    MDR report key: 20153141 · Received September 5, 2024

    Report

    Report Number
    3013017877-2024-00062
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 5, 2024
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527772064
    PMA / PMN Number
    P190021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR SCHEDULED THE PATIENT TO UNDERGO REVISION SURGERY BECAUSE THE X-RAY TAKEN AT THE DOCTOR'S OFFICE SHOWED LEAD MIGRATION; THEREFORE, THE DOCTOR DECIDED TO REPLACE BOTH LEADS. THE PHYSICIAN MADE MIDLINE AND POCKET INCISIONS IN THE OPERATING ROOM. THEN, A SQUARED IMAGE WAS TAKEN, WHICH SHOWED THAT THE LEADS WERE IN THE PROPER POSITION, THE IMPEDANCES WERE WITHIN THE RANGE, AND THE DEVICE PROVIDED A GOOD TWITCH BILATERALLY. THE SURGEON DECIDED NOT TO REPLACE THE LEADS, AND THE INCISIONS WERE CLOSED WITHOUT COMPLICATIONS. THERE WAS NO LEAD MIGRATION, AND THE DEVICE REMAINS IMPLANTED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042351 REACTIV8 REACTIV8 STIMILATION LEAD QLK MAINSTAY MEDICAL LIMITED 8145 05391527772064

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male