BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 7445868 · Received April 19, 2018

    Report

    Report Number
    1644487-2018-00617
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    April 27, 2018
    Report Date
    February 22, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE SUPPLEMENTAL MDR 4: "IT WAS REPORTED THAT THE MOTHER WAS HOPEFUL THAT A REPLACEMENT GENERATOR WOULD NOT BE IMPACTED BY WIFI THE PATIENT'S GENERATOR WAS REPLACED. IMPEDANCE WAS OK PRIOR TO REPLACEMENT."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT'S VNS WAS CAUSING HIM TO HAVE INCREASED SEIZURE FREQUENCY AND INTENSITY WITH THE SETTINGS INCREASED. SHE LATER REPORTED THAT THE SETTINGS WERE TURNED BACK DOWN, AND HE WAS DOING BETTER. THE PHYSICIAN REPORTEDLY TOLD THE MOTHER THAT THE VNS COULD BE INTERFERING WITH THE PATIENT'S OTHER NERVES, BUT NO OTHER INFORMATION WAS GIVEN REGARDING THAT STATEMENT. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PATIENT'S VNS WAS TURNED OFF AT HIS LAST APPOINTMENT WITH THE PHYSICIAN. THE PATIENT'S MOTHER REQUESTED THAT IT BE TURNED OFF BECAUSE SHE THOUGHT HE WAS DOING SO MUCH BETTER WITHOUT IT ON. THE PHYSICIAN STATED THAT THE CAREGIVER THAT WAS WITH THEM REPORTED THAT THE VNS WAS HELPING THE PATIENT AND CONTROLLING HIS SEIZURES. THE PHYSICIAN DID NOT UNDERSTAND WHY THE MOTHER WANTED THE DEVICE OFF, BUT HE DID IT ANYWAYS DUE TO THE MOTHER'S REQUEST. THE MOTHER STATED THAT THE "HARDWARE WORKS PERFECT BUT IT'S GOT A HOLD OF THE NERVE ENDS." IT WAS UNKNOWN WHAT SHE MEANT AS THE PHYSICIAN BELIEVED THAT THERE WAS NOTHING WRONG WITH THE DEVICE. THE PHYSICIAN DID NOT BELIEVE THAT THE DEVICE WAS AFFECTING THE PATIENT'S NERVES (OTHER THAN THE NORMAL VNS STIMULATION ON THE VAGUS NERVE). NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THE PATIENT WAS TRULY DISABLED BASED ON A SESSION REPORT. NO FURTHER RELEVANT INFORMATION RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MOTHER BELIEVED THAT WI-FI WAS CAUSING THE PATIENT TO HAVE MORE FREQUENT AND INTENSE SEIZURES. WI-FI IS NOT EXPECTED TO IMPACT A PATIENT'S DEVICE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTHER WAS HOPEFUL THAT A REPLACEMENT GENERATOR WOULD NOT BE IMPACTED BY WIFI THE PATIENT'S GENERATOR WAS REPLACED. IMPEDANCE WAS OK PRIOR TO REPLACEMENT. RETURN OF THE EXPLANTED PRODUCT IS NOT EXPECTED.

    Description of Event or Problem · 1

    IT WAS FOUND THAT, BASED ON THE DATA IN THE MANUFACTURER'S PROGRAMMING DATABASE, THE PATIENT'S GENERATOR WAS NOT TURNED OFF AS REPORTED BY THE PATIENT'S MOTHER, BUT WAS LEFT AT 0.25 MA OUTPUT CURRENT. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285969 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 3134

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention