MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

Model Number 8103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Depression (2361)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported that the clinical study patient has post surgical pain which is definitely related to implant and not related to stimulation/device.Medication was provided, it was not noted to be a serious injury.It was then reported that the patient has worsened depression due to post-surgical pain which is severe.It is definitely related to implant procedure and not related to stimulation/device.It is recovering/resolving.No further relevant information has been received to date.

Manufacturer Narrative

D4: corrected data, initial report: did not include lot number and expiration date.H4: corrected data, initial report: did not include manufacturing date.

Event Description

It was specified that the post surgical pain is in the upper left chest area and left arm (muscle strain).No further relevant information has been received to date.

Manufacturer Narrative

B5.Corrected information, initial report: inadvertently did not report that the events resolved.

Event Description

The pain and increased depression resolved.No further relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• Type of Device: GENERATOR
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13029025
• MDR Text Key: 284807264
• Report Number: 1644487-2021-01791
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2023
• Device Model Number: 8103
• Device Lot Number: 6953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 02/08/2022; 04/01/2022
• Supplement Dates FDA Received: 01/11/2022; 03/04/2022; 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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: 48 YR
• Patient Sex: Female