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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's device showed high impedance.No known surgical interventions have occurred to date.
Event or Problem Description
Patient underwent generator and lead revision surgery.The explanted lead has not been received to date.
Event or Problem Description
High impedance was observed prior to surgery.During surgery, the surgeon did check lead pin insertion and no issues were observed.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8149386
• Report Number: 1644487-2018-02263
• Device Sequence Number: 1684112
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2018

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: 08/10/2014
• Device Model Number: 303-30
• Device Lot Number: 2754
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 01/08/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/07/2019; 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR