BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 15230981 · Received August 16, 2022

    Report

    Report Number
    3013017877-2022-00010
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    July 28, 2022
    Report Date
    December 14, 2022
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: SUSPECTED OR ALLEGED INFECTION. MML COMPLAINT REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    THE IMPLANTABLE PULSE GENERATOR AND STIMULATION LEADS WERE RETURNED FOR ANALYSIS. ALTHOUGH THERE WAS NO ALLEGATION AGAINST THE FUNCTION OF THE IPG AND THE STIMULATION LEADS, THE IPG PASSED THE FUNCTIONAL TEST AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. THE STIMULATION LEADS WERE CUT DURING THE EXPLANT PROCEDURE. THEREFORE, THERE WAS NO FUNCTIONAL TESTING PERFORMED. THE DEVICE HISTORY RECORD REVIEW REVEALED NO EVIDENCE OF A NONCONFORMANCE FOUND DURING MANUFACTURING OF THESE DEVICES THAT COULD HAVE CONTRIBUTED TO THE SUSPECTED INFECTION REPORTED BY THE PATIENT OR SURGEON. SUSPECTED OR ALLEGED INFECTION. MML COMPLAINT REFERENCE # (B)(4).

    Description of Event or Problem · 0

    ON JULY 28, 2022, MML RECEIVED INFORMATION STATING THAT THE REACTIV8 SYSTEM WAS EXPLANTED ON (B)(6) 2022 DUE TO A SUSPECTED OR ALLEGED INFECTION. REPORTEDLY, THE PATIENT'S WOUND WAS NOT CLOSING AND IT WAS STILL WEEPING. ON (B)(6) 2022, MML REQUESTED THE RESULT OF THE CULTURE. ACCORDING TO THE REPORTER, THE PATIENT WAS ON ANTIBIOTICS IN ADVANCE, SO THERE WAS NO OPPORTUNITY FOR STERILE CULTURE AND NO SIGNIFICANT PURULENT BURDEN. IT APPEARED TO BE FAT NECROSIS OR INJECTION. THE DEVICE WAS EXPLANTED SUCCESSFULLY WITH NO REPORT OF PATIENT HARM OR INJURY DUE TO EXPLANT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, MML RECEIVED INFORMATION STATING THAT THE REACTIV8 SYSTEM WAS EXPLANTED ON (B)(6) 2022 DUE TO A SUSPECTED OR ALLEGED INFECTION. REPORTEDLY, THE PATIENT'S WOUND WAS NOT CLOSING AND IT WAS STILL WEEPING. ON (B)(6) 2022, MML REQUESTED THE RESULT OF THE CULTURE. ACCORDING TO THE REPORTER, THE PATIENT WAS ON ANTIBIOTICS IN ADVANCE, SO THERE WAS NO OPPORTUNITY FOR STERILE CULTURE AND NO SIGNIFICANT PURULENT BURDEN. IT APPEARED TO BE FAT NECROSIS OR INJECTION. THE DEVICE WAS EXPLANTED SUCCESSFULLY WITH NO REPORT OF PATIENT HARM OR INJURY DUE TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011812 REACTIV8 IMPLANTABLE PULSE GENERATOR (IPG) QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other