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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 Problem Discomfort (2330)
Event Date 02/20/2024
Event Type  Injury  
Event Description
It was initially reported that the patient started having pain with stimulation near their ear and jaw.Physician adjusted settings, and per regional manager, diagnostics were normal.Information was later received that the patient has left-sided jaw pain that radiates to her temporomandibular joint (tmj) causing her to tear every time the device shocks.Since the patient experiences jaw pain with every stimulation, physician may send patient back to surgeon to consider replacing the generator.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
 
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
The patient's physician later reported that the referral to their surgeon was medical intervention was taken to preclude serious injury.The patient had a prophylactic battery replacement.The explanted device is not available for return to the manufacturer, indicating it has likely been discarded.
 
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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 Key19096959
MDR Text Key340031770
Report Number1644487-2024-00416
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 05/07/2024
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 Date07/17/2021
Device Model Number1000
Device Lot Number205015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 03/19/2024
Initial Date FDA Received04/12/2024
Supplement Dates Manufacturer Received04/12/2024
Supplement Dates FDA Received05/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2019
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) Other;
Patient Age25 YR
Patient SexFemale
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