BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 16010108 · Received December 19, 2022

    Report

    Report Number
    3013017877-2022-00027
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    November 18, 2022
    Report Date
    February 16, 2023
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MAINSTAY MEDICAL LIMITED (MML) COULD NOT RETRIEVE THE DEVICE BECAUSE MML WAS NOT TOLD ABOUT THE EXPLANT PROCEDURE UNTIL FIVE DAYS LATER. THE HOSPITAL STAFF DISCARDED THE DEVICE. MML REF# (B)(4).

    Additional Manufacturer Narrative · 0

    MAINSTAY MEDICAL LIMITED (MML) COULD NOT RETRIEVE THE DEVICE BECAUSE MML WAS NOT TOLD ABOUT THE EXPLANT PROCEDURE UNTIL FIVE DAYS LATER. THE HOSPITAL STAFF DISCARDED THE DEVICE. THE DEVICE MANUFACTURING AND STERILIZATION RECORD WERE REVIEWED. ALL PASSED THE STERILIZATION PROCESS, AND NO OBSERVATION WOULD HAVE CONTRIBUTED TO THE CONFIRMED INFECTION. UPDATED B2 OTHER: INFECTION (STAPH). OTHER DEVICE: STIMULATION LEADS, SERIAL NUMBER: (B)(6). MML (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITE, ALONG WITH FEVER AND NAUSEA. THE PHYSICIAN ON CALL DECIDED TO EXPLANT THE DEVICE ON (B)(6), 2022. THE RESULT OF THE CULTURE WAS POSITIVE FOR STAPH INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITE, ALONG WITH FEVER AND NAUSEA. THE PHYSICIAN ON CALL DECIDED TO EXPLANT THE DEVICE ON (B)(6) 2022. THE RESULT OF THE CULTURE WAS POSITIVE FOR STAPH INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192182 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other| R