BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16075673 · Received December 29, 2022

    Report

    Report Number
    1644487-2022-01686
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 7, 2022
    Report Date
    March 23, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    B5. CORRECTED DESCRIPTION OF EVENT, INITIAL REPORT: INADVERTENTLY LEFT OUT INFORMATION REGARDING THE INCREASE IN SEIZURES. F10. CORRECTED CLINICAL CODE, INITIAL REPORT: INADVERTENTLY LEFT OUT ADDITIONAL E010901 CODING FOR SEIZURES. F10. CORRECTED IMPACT CODE, INITIAL REPORT: INADVERTENTLY LEFT OUT ADDITIONAL F0101 CODING FOR THERAPEUTIC RESPONSE DECREASED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DOSING APPOINTMENT FOR PATIENT THAT WHEN TRYING TO RUN A DIAGNOSTICS THEY ALSO KEPT GETTING AN ERROR CODE 254 AND 128. THE PATIENT ALSO HAD LOW OUTPUT CURRENT. LATER, IT WAS ALSO CONFIRMED PATIENT HAD A LOW IMPEDANCE. IT WAS LATER REPORTED THAT THE PATIENT WAS NOT DISPLAYING ANY SYMPTOMS OF LOSS OF VNS THERAPY. THERE WAS NO GENERATOR RESET PERFORMED. SINCE ERROR CODE 254 WAS SEEN WITH LOW OUTPUT CURRENT AND LOW IMPEDANCE AFTER DIAGNOSTICS, A REED SWITCH MALFUNCTION IS THE MOST PROBABLY CAUSE TO DATE. AS WE RECEIVE MORE INFORMATION WE WILL CONTINUE TO EVALUATE. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. 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 KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PHYSICIAN LATER REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE LOW IMPEDANCE DID NOT OCCUR AFTER ATTEMPTING A GENERATOR RESET. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    TROUBLESHOOTING ATTEMPTS SUCH AS RAPID MAGNET SWIPES AND A GENERATOR RESET WERE PERFORMED TO TRY TO ¿UNSTICK¿ THE REED SWITCH. HOWEVER, THIS WAS UNSUCCESSFUL. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    INTERNAL GENERATOR DATA WAS RECEIVED AND REVIEWED. THE DATA WAS CONSISTENT WITH THAT OF A STUCK REED SWITCH MALFUNCTION. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524014 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205816 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other