BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 7567587 · Received June 4, 2018

    Report

    Report Number
    1644487-2018-00931
    Event Type
    Injury
    Date Received
    June 4, 2018
    Report Date
    September 27, 2018
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750054
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR? - DEVICE EVALUATION IS NOT NECESSARY AS THE REPORTED EVENTS ARE NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: FOLLOW-UP REPORT #02 INADVERTENTLY DOCUMENTED AWARE DATE (B)(4) 2018 INSTEAD OF (B)(4) 2018.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE MENTIONED THAT THE GENERATOR MIGRATION OR OTHER NORMAL BODY MOVEMENTS MAY HAVE ALSO CONTRIBUTED TO SLIPPAGE OF THE LEAD PIN FROM THE GENERATOR HEADER.

    Description of Event or Problem · 1

    THE PHYSICIAN BELIEVED THAT THE WEIGHT OF THE GENERATOR MAY HAVE EXCEEDED THE STRENGTH OF THE SUTURE AND THE PATIENT'S SOFT TISSUE, LEADING TO THE GENERATOR MIGRATION. THE PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH SMALLER-SIZED GENERATORS. THE PHYSICIAN CONFIRMED THAT NON-ABSORBABLE SUTURES WERE USED DURING THE INITIAL IMPLANT OF THE MIGRATING GENERATOR TO SECURE THE GENERATOR TO THE TISSUE. THE PHYSICIAN NOTED THAT HE TOOK EXTRA CARE TO SECURE THE NEWLY-IMPLANTED GENERATOR WITH A NON-ABSORBABLE SUTURE AND REDUCE THE SIZE OF THE GENERATOR POCKET TO PREVENT FUTURE GENERATOR MIGRATION. THE PHYSICIAN BELIEVED THAT THE GENERATOR MIGRATION CONTRIBUTED TO TENSION ON THE LEAD WIRE NEAR THE BASE OF THE CONNECTOR PIN, CAUSING ONE OF THE LEAD FRACTURES DESCRIBED IN THE PRODUCT ANALYSIS REPORTED IN MFR. REPORT #1644487-2016-00868. THREE CHEST X-RAY IMAGES WERE REVIEWED. THE PROVIDED X-RAY IMAGES SPANNED MULTIPLE YEARS OVER THE 3-YEAR IMPLANT LIFE OF THE GENERATOR. THE GENERATOR WAS PLACED NORMALLY IN THE PATIENT¿S LEFT CHEST. THE GENERATOR APPEARED TO MOVE TO A LOWER POSITION BETWEEN THE THREE IMAGES PROVIDED OVER THE IMPLANT LIFE OF THE GENERATOR; HOWEVER, IT IS RELEVANT TO NOTE THAT THE PATIENT APPEARED TO BE IN DIFFERENT POSITIONS WITH VARYING DEGREES OF SHOULDER MOVEMENT IN EACH OF THE IMAGES. IT APPEARED IN THE PROVIDED IMAGES THAT THE MIGRATION OF THE GENERATOR CONTRIBUTED TO INCREASED TENSION ON THE LEAD AT BASE OF THE CONNECTOR PIN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN DID NOT PURSUE SURGERY IN ORDER TO ADDRESS THE MIGRATION, AND THE SURGERY OCCURRED ONLY TO ADDRESS THE HIGH LEAD IMPEDANCE. THE PHYSICIAN BELIEVED THAT THERE WAS A POSSIBILITY THE MIGRATION MAY HAVE CONTRIBUTED TO THE HIGH IMPEDANCE; HOWEVER, HIGH IMPEDANCE WAS PRESENT FOR THE PATIENT'S VNS SYSTEM BEFORE MIGRATION WAS OBSERVED BY THE PHYSICIAN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    X-RAYS WERE RECEIVED BY THE MANUFACTURER FOR A REPORT OF HIGH IMPEDANCE FOR A PATIENT'S DEVICE. THIS REPORT OF HIGH IMPEDANCE IS CAPTURED IN MFR. REPORT # 1644487-2016-00868. IN THE CONTEXT OF THE PROVIDED X-RAYS, THE PHYSICIAN ALSO REPORTED THAT THE GENERATOR APPEARED TO BE POSITIONED TWO RIBS LOWER THAN ITS ORIGINAL IMPLANT LOCATION. DUE TO THE SCOPE OF THE PROVIDED X-RAY IMAGES, MIGRATION COULD NOT BE ASSESSED. THE PATIENT UNDERWENT LEAD AND PROPHYLACTIC GENERATOR REPLACEMENT SURGERY IN RESPONSE TO THE HIGH IMPEDANCE; HOWEVER, IT IS UNKNOWN IF THE PHYSICIAN ALSO PURSUED SURGERY IN ORDER TO ADDRESS THE MIGRATION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409878 PULSE GEN MODEL 105 GENERATOR LYJ LIVANOVA USA, INC. 105 203322 05425025750054

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention