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 Problems Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815); Paralysis (1997); Sore Throat (2396); Ambulation Difficulties (2544)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that following vns implant surgery the patient experienced difficulty swallowing, voice alteration, and aspiration.The physician assessed that these events were severe.It was noted that intervention was required to preclude serious injury/death, although the intervention has not been clarified (the patient has not gone to the hospital).Diagnostics examinations/tests were required.No additional relevant information has been received to date.

Event Description

Additional information was received regarding a report of vocal cord paralysis for the same patient, which is likely related to the dysphagia, voice alteration, and aspiration.No additional relevant information has been received to date.

Event Description

It was noted that the patient also experienced a sore throat leading to hospitalization.It was noted that the aspiration, difficulty swallowing, and sore throat were all possibly related to the implant procedure.The aspiration and sore throat have recovered/resolved, and the difficulty swallowing is resolving.No additional relevant information has been received to date.

Event Description

Additional information received noting that the reported vocal cord paralysis now has an outcome of 'recovered/resolved'.

Event Description

Additional information received noting that the reported vocal cord paralysis now has an outcome of 'not recovered/not resolved'.

Event Description

Additional information received noting that the vocal cord paralysis is possibly related to vns stimulation.

Manufacturer Narrative

B5 describe event or problem, corrected data: supplemental #05 report inadvertently left out relevant information f10 adverse event problem, corrected data: supplemental #05 report inadvertently left out codes 'e2302' and 'f2303'.

Event Description

Information obtained noting that since implant the patient has experienced voice loss and vocal cord paralysis that has not resolved and episodes of falling.The patient was recently hospitalized due to her falls and was diagnosed with parotid gland infection and is questioning if this could be caused by the vns.The patient was treated with antibiotics.The vocal cord paralysis is now noted to have an outcome of not recovered/ not resolved and has unknown relationship to implant procedure/device and stimulation.

Event Description

Additional information received noting that the reported vocal cord paralysis not has an outcome of recovered/resolved.The reported falling was assessed as not being related to vns and the reported difficulty swallowing and aspiration or no longer reportable as they are likely being grouped under the vocal cord paralysis.

Event Description

As the vocal cord paralysis reported occurred within three months of the lead being implanted, it can be concluded as being related to the vns implant surgery.

Event Description

Additional information received noting that the reported vocal cord paralysis is possibly related to the implant procedure and not related to stimulation/device.The event has an outcome of recovered/resolved.The severity is noted to be moderate.

• 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: 12988869
• MDR Text Key: 284807602
• Report Number: 1644487-2021-01737
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750511
• UDI-Public: 05425025750511
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/13/2023

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: 07/14/2023
• Device Model Number: 8103
• Device Lot Number: 6911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/14/2021; 02/01/2022; 05/05/2022; 06/01/2022; 07/13/2022; 08/24/2022; 09/21/2022; 08/24/2022; 09/20/2023
• Supplement Dates FDA Received: 01/07/2022; 02/25/2022; 05/25/2022; 06/23/2022; 08/03/2022; 08/24/2022; 10/07/2022; 08/04/2023; 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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): Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female