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	01/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Generator was explanted and returned due to premature end of life (captured in mfr report #1644487-2018-02279.Product analysis was completed for the generator.Review of the data dump associated with generator product analysis revealed high impedance.No known surgical intervention has occurred to date.No other relevant information has been received to date.
Event or Problem Description
Information was received that high impedance >9000 ohms was seen on the patient¿s m1000 generator.This is likely a continuation of the patient¿s past fluctuating high impedance since the affected lead is still implanted in the patient.No known surgical intervention for the lead has occurred 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: 8600484
• Report Number: 1644487-2019-00904
• Device Sequence Number: 14026813
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 05/18/2015
• Device Model Number: 303-30
• Device Lot Number: 201776
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR