BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 20097570 · Received August 29, 2024

    Report

    Report Number
    3013017877-2024-00059
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 24, 2024
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE #:(B)(4). OTHER DEVICE EXPLANTED: MODEL: 8145 DESCRIPTION: PERCUTANEOUS STIMULATION LEAD. SERIAL NUMBERS: (B)(6)/ (B)(6). UDI #: (B)(4).(B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PERFORMED. NO OBSERVATION WAS IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE PATIENT'S PAIN. THE IPG PASSED THE FUNCTIONAL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED ON THE RETURNED LEADS. BOTH LEADS WERE RECEIVED IN TWO SEGMENTS. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO RELEVANT NON-CONFORMANCES WERE FOUND.

    Additional Manufacturer Narrative · 0

    REFERENCE #: (B)(4). OTHER DEVICE EXPLANTED: MODEL: 8145.DESCRIPTION: PERCUTANEOUS STIMULATION LEAD SERIAL NUMBERS: (B)(6) / (B)(6). UDI #: (B)(4), (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT POST-OPERATIVE POCKET PAIN AND WAS UNWILLING TO CONTINUE WITH THERAPY. REPORTEDLY, TOLERABILITY TESTING SHOWED THE PATIENT WAS EXTREMELY SENSITIVE AND REPORTED DISCOMFORT EVEN AT EXTREMELY LOW AMPLITUDE. THE DEVICE WAS EXPLANTED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT POST-OPERATIVE POCKET PAIN AND WAS UNWILLING TO CONTINUE WITH THERAPY. REPORTEDLY, TOLERABILITY TESTING SHOWED THE PATIENT WAS EXTREMELY SENSITIVE AND REPORTED DISCOMFORT EVEN AT EXTREMELY LOW AMPLITUDE. THE DEVICE WAS EXPLANTED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802011 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other