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

Model Number	303-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was referred for full revision (replacement of the lead and generator) due to low battery and high lead impedance.No known surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Explanted generator was received by product analysis.Product analysis has not been completed to date.Further information was received from the physician that pin re-insertion was not attempted during surgery and that the lead was not replaced as impedance was ok after generator replacement.
Event or Problem Description
Patient underwent generator replacement.The implant card received for the patient indicated that the generator was replaced due to high impedance and prophylactic.The explanted generator has not been received by product analysis to date.No other relevant information has been received to date.
Event or Problem Description
Generator product analysis was completed.The product analysis lab confirmed that the generator was at normal ifi=no condition.There were no performance of any other type of adverse events found with the pulse generator.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8496049
• Report Number: 1644487-2019-00683
• Device Sequence Number: 1780878
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/08/2019

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: 07/22/2019
• Device Model Number: 303-30
• Device Lot Number: 4429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Event Location: Other
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 05/30/2019; 07/01/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/31/2019; 06/20/2019; 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR