BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16280631 · Received February 1, 2023

    Report

    Report Number
    1644487-2023-00093
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 3, 2023
    Report Date
    March 9, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 0

    THE PATIENT HAD THEIR MAGNET TAPED OVER THE VNS AND WHEN REMOVED TO HAVE THEIR DEVICE INTERROGATED THEY RECEIVED A MESSAGE NOTING THAT CURRENT CANNOT BE DELIVERED. THE MAGNET WAS SWIPED TO SEE IF THE PATIENT COULD PERCEIVE STIMULATION BUT THE PATIENT DID NOT FEEL ANYTHING. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT HAD THE MAGNET TAPED OVER THEIR GENERATOR AS THE CURRENT WAS TOO STRONG AND CAUSED PAIN THAT THE PATIENT COULD NOT TOLERATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR WAS RECEIVED BUT PRODUCT ANALYSIS IS STILL UNDERWAY. INTERNAL DATA FROM THE SUSPECT GENERATOR WAS RECEIVED AND REVIEWED. INTERNAL INVESTIGATION INTO CONFIRMED CASES 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.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. AN INTERROGATION AND A SYSTEM DIAGNOSTIC TEST WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN IFI=NO CONDITION) WAS PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE PA WORKSHEETS WERE REVIEWED AND NO ANOMALIES WERE NOTED. THE DATA DUMP WAS REVIEWED AND THE DEVICE DROPPED TO LOW IMPEDANCE ON (B)(6) 2023 WHICH IS EXPECTED WITH REED SWITCH MALFUNCTIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033892 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 6169 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male