BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR MODEL 1000

    MDR report key: 20537727 · Received October 25, 2024

    Report

    Report Number
    1644487-2024-01356
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    May 24, 2024
    Report Date
    December 3, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Additional Manufacturer Narrative · 0

    D1. BRAND NAME - CORRECTION - INADVERTENTLY DID NOT INCLUDE GENERATOR MODEL 1000 IN THE INITIAL MDR SUBMITTED. D4. MODEL # - CORRECTION - INADVERTENTLY DID NOT INCLUDE 1000 IN THE INITIAL MDR SUBMITTED. F10. DEVICE CODE - CORRECTION - INADVERTENTLY CODED E2403 IN THE INITIAL MDR SUBMITTED. H6. TYPE OF INVESTIGATION - CORRECTION - INADVERTENTLY DID NOT CODE B01 AND B17 IN THE INITIAL MDR SUBMITTED.

    Description of Event or Problem · 0

    MEDWATCH REPORT #MW5160279 WAS RECEIVED AND REVIEWED BY THE MANUFACTURER. IT WAS REPORTED THAT THEY EXPERIENCED A FAULTY REED SWITCH WHICH LEAD TO A SURGICAL PROCEDURE FOR A DEVICE REPLACEMENT IN 2024. THE PATIENT WAS TOLD THE REASON FOR DEVICE ISSUE WAS STATED TO BE A MALFUNCTIONING REED SWITCH. INTERNAL INVESTIGATION INTO SIMILAR EVENTS WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE OF REED SWITCH FAILURES. THE PRIMARY ROOT CAUSE IS BELIEVED TO BE REED SWITCHES STICKING IN THE CLOSED POSITION AFTER EXTENDED EXPOSURE TO MAGNETIC FIELDS. THE INVESTIGATION ALSO IDENTIFIED RESIDUAL MAGNETIC PROPERTIES OF THE GENERATOR BATTERY TO BE A POTENTIAL CONTRIBUTOR; HOWEVER, TESTING PERFORMED DURING THE INVESTIGATION FOUND THE EFFECT TO BE HIGHLY VARIABLE WITH EACH MAGNETIC FIELD EXPOSURE AND ANY CLOSURE OF THE REED SWITCH IMPACTED BY THIS PHENOMENON WOULD LIKELY BE REVERSED BY SUBSEQUENT SWIPING OF THE PATIENT MAGNET. THUS, THE MOST LIKELY CONTRIBUTOR OF THE IDENTIFIED COMPLAINTS IS CONSIDERED TO BE MECHANICAL STICKING OF THE REED SWITCH BLADES. NO OTHER SPECIFIC DETAILS REGARDING THE FDA REPORTABLE EVENT WAS PROVIDED BY THE ANONYMOUS REPORTER. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819061 GENERATOR MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown