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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Choking (2464); Cough (4457)
Event Date 12/09/2022
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that patient experienced an increase perception of stimulation accompanied by a tickle in his throat that progressed to coughing, choking, and difficulty breathing as the perception of stimulation increased throughout the day.The patient reports feeling the device continuously stimulating.The patient got on a facetime call with the managing physician who instructed the patient to hold the magnet over his chest to disable the stimulation.This reportedly did not work and the patient called ems who arrived and taped the magnet over his chest which disabled stimulation.The patient was taken to the hospital where the managing physician arrived to disable the device.It was noted that the patient is taking anticonvulsant medications.Tablet data was received and the decoder for the patient's device was reviewed.Therapy was delivered as programmed.The patient was seen to be set to the lowest autostim threshold of 20%.A review of the hourly tab indicated that the patient received several autostims ranging from 9 per hour to 135 per hour.The patient's foreground heartrate was seen at an average of 120bpm no anomalies from the decoder were seen.Further information was received from the managing physician who confirmed the events took place as reported and that disabling the device was to preclude a potential serious injury.The low autostim threshold was discussed and concluded that the patient was receiving stimulation from an elevated heart rate not associated with any seizure event, that the physician had the autostim threshold set too low for the patient.The physician plans to resume therapy for the paitient with a more appropriate autostim threshold.Device history records were reviewed.The device passed all functional and quality testing prior to distribution.No other relevant information has been received to date.
 
Event Description
It was later reported that therapy has been re-enabled.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key16103528
MDR Text Key306716798
Report Number1644487-2023-00009
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/10/2020
Device Model Number1000
Device Lot Number205042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/11/2022
Initial Date FDA Received01/05/2023
Supplement Dates Manufacturer Received03/06/2024
Supplement Dates FDA Received03/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexMale
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