BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15627501 · Received October 18, 2022

    Report

    Report Number
    1644487-2022-01300
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    April 26, 2022
    Report Date
    December 29, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 EXPLANTED GENERATOR WAS RECEIVED BY PRODUCT ANALYSIS, AND SUCCESSFULLY UNDERWENT ANALYSIS IN WHICH A REED SWITCH RELATED ISSUE WAS POSITIVELY IDENTIFIED WITHIN THE GENERATOR. IT WAS DETERMINED THAT THE REED SWITCH WAS LIKELY STUCK CLOSED. OUTSIDE OF THIS IDENTIFIED REED SWITCH ISSUE, NO OTHER ANOMALIES WERE IDENTIFIED. THE REPORTED LOW IMPEDANCE WAS CAUSALITY OF THE REED SWITCH ISSUE (THIS IS AN EXPECTED EVENT). NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN TO HAVE LOW IMPEDANCE SEVERAL WEEKS AFTER GENERATOR WAS IMPLANTED. X-RAYS WERE TAKEN AND DETERMINED TO BE "NORMAL" PER THE PHYSICIAN. THE PATIENT HAD THEN UNDERGONE REVISION SURGERY. THE LEAD PIN HAD BEEN UNPLUGGED, CLEANED AND REINSERTED INTO THE GENERATOR. THE LOW IMPEDANCE REMAINED. THE GENERATOR WAS THEN REPLACED, THE LOW IMPEDANCE HAD BEEN RESOLVED WHEN THE GENERATOR WAS REPLACED. THE REP NOTED THAT THE EXPLANTED GENERATOR WILL BE RETURNED TO (B)(4). THE PRODUCT 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
    2306429 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 588 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown