MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number	303-30
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the generator showed high impedance during a prophylactic replacement surgery.Troubleshooting was attempted on this generator by running a systems diagnostics test four times, and disconnecting the pin and wiping it off between tests.The previous generator was interrogated prior to surgery and was found to not have high impedance.The device is still undergoing product analysis.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.
Event or Problem Description
Product analysis was approved and completed.An interrogation, system diagnostic tests, and a comprehensive automated electrical evaluation (shows an intensified follow-up indicator=no condition) were performed.No anomalies were seen, and the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Product analysis worksheet was reviewed and no anomalies were seen.No other relevant information has been received to date.
Additional Manufacturer Narrative
D1: brand name, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.D2: name, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.D4: model #, serial #, lot #, expiration date, udi, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.D6a: implant date, corrected data:the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.D6b: explant date, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.D9: corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.F10: component code, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.H3: device evaluation, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.H4: manufacture date, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.H6: type of investigation, corrected data: the initial reporter inadvertently did not correct the suspect device based on findings from product analysis.
Event or Problem Description
After the completion of product analysis, the generator was confirmed to have not caused the high impedance as it was functioning as expected during testing.The lead was then updated to the suspect product.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17405883
• Report Number: 1644487-2023-00999
• Device Sequence Number: 7121399
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/19/2019
• Device Model Number: 303-30
• Device Lot Number: 203487
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 10/27/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/06/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male