BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 16014913 · Received December 20, 2022

    Report

    Report Number
    1644487-2022-01647
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 30, 2022
    Report Date
    February 16, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750047
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    PRODUCT ANALYSIS HAS BEEN COMPLETED. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE IMPLANT WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE PULSE DISABLED EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE DEVICE WAS RECEIVED INTO PRODUCT ANALYSIS WHICH IS UNDERWAY BUT NOT YET COMPLETED. DECODER REVIEW WAS COMPLETED FROM PROGRAMMING TABLET DATA RECEIVED. THE BEHAVIOR OF THE GENERATOR IS CONSISTENT WITH ASIC LATCH-UP CONDITION /EXPOSURE TO ELECTROSURGICAL EQUIPMENT OR ELECTROSTATIC DISCHARGE AS A LARGE VOLTAGE DROP WAS SEEN FROM NORMAL DURING PRE OP INTERROGATION TO LOW DURING OPERATION. THE INTIAL TEMPERATURE WAS SEEN TO BE SLIGHTLY LOW HOWEVER THE DATA SUGGESTS THAT ASIC LATCHUP / ELECTROSTATIC DISCHARGE TO BE THE PRIMARY CAUSE OF THE EVENT. THIS EVENT MEETS THE LIMITED INVESTIGATION CIRTERIA FOR A PREVIOUS INVESTIGATION OF HISTORICAL DATA INTO ASIC LATCHUP EVENTS ASIC DUE TO ELECTROMAGNETIC INDUCTION (EMI) OR ELECTROSTATIC DISCHARGE (ESD) TRANSIENTS LEADING TO PREMATURE BATTERY DEPLETION. IT IS CONCLUDED THAT SURGEON ERROR CAUSED THE EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BATTERY REPLACEMENT PROCEDURE A BRAND NEW GENERATOR WAS SEEN TO RECEIVE ERROR CODE 8 BATTERY AT EOS. THE GENERATOR WAS INTERROGATED MULTIPLE TIMES. REPORTEDLY, NO ELECTROCAUTERY WAS USED NEAR THE DEVICE. THEY ATTEMPTED TO PROGRAM THE DEVICE SETTINGS AND RECEIVED THE SAME ERROR CODE 8 INDICATING BATTERY WAS AT EOS. THE OLD DEVICE WAS RECONNECTED. DEVICE HISTORY RECORDS WERE REVIEWED. THE DEVICE PASSED ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. THE DEVICE IS SCHEDULED FOR RETURN BUT HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571495 PULSE GEN MODEL 104 GENERATOR LYJ LIVANOVA USA, INC. 104 205818 05425025750047

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male