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

Model Number	303-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was reported to be referred for surgery due to the lead being too tight and pulling when the patient turns his head.It was noted that during the surgery the lead wire would be loosened in the neck and chest area.It was noted that product replacement was not expected.No known surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Further information was received that the patient underwent surgery.It was noted that no replacement products (lead or generator) were opened or implanted.Instead, a couple of the patient's sutures were loosened as well as the lead.It was noted that device placement was still the same as at implant and no changes were made to the generator or settings.It was noted that there was no further patient complaint of the reported events.
Event or Problem Description
Further information was received from the patient's physician that the physician's assessment of the cause of the event was patient manipulation or trauma.It was confirmed that a non-absorbable suture was used to secure the generator during implant.It was noted that inadequate strain relief due to patient anatomy may also be contributing to the event.The physician noted that surgical intervention would be to free up tightness in the lead to prevent damage to the vagal nerve.
Additional Manufacturer Narrative
Corrected data, version no 1: inadvertently stated that per the physician the events were due to patient manipulation or trauma instead of were not due to patient manipulation or trauma.
Event or Problem Description
Further information was received from the patient's physician that the events were not related to patient manipulation or trauma.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9488395
• Report Number: 1644487-2019-02459
• Device Sequence Number: 16607798
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/18/2023
• Device Model Number: 303-30
• Device Lot Number: 6182
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 01/16/2020; 01/30/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/16/2020; 01/16/2020; 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR