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

Model Number 303-20

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 10/25/2019

Event Type  malfunction  

Event Description

A device deficiency was reported for a study patient; however, no additional details were provided.It was later reported that the patient underwent a lead "re-positioning" surgery due to the lead being in the wrong position.No other relevant information has been received to date.

Event Description

Further information was received from the clinical study team indicating that the event was inadvertently associated and reported for the incorrect patient in the study database.The event and correctly associated patient were previously reported in mfr.Report #1644487-2019-01906.Any further information related to the report will be captured within mfr.Report #1644487-2019-01906.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9342895
• MDR Text Key: 167032952
• Report Number: 1644487-2019-02218
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2022
• Device Model Number: 303-20
• Device Lot Number: 5661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR