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 Code	Pain (1994)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported that the patient was scheduled for a possible lead and generator replacement surgery, and information was later received that the surgery was being taken due to tightness/pain in the neck area.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.
Event or Problem Description
The patient underwent a lead and generator replacement.The reason for generator replacement was indicated as prophylactic.The explant facility historically discards explanted products; therefore, the return of the suspect device is not expected to date.No further 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
• MDR Report Key: 8574755
• Report Number: 1644487-2019-00841
• Device Sequence Number: 16666815
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 06/07/2021
• Device Model Number: 303-30
• Device Lot Number: 5322
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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: 29 YR