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

Model Number 8103

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that the patient is seen to be at an intensive follow-up indicator during their 5 month clinic visit.A month prior, the battery life was "ok".No other relevant information has been received to date.

Event Description

A second review of the generator's data was performed, in which the likely fault was confirmed.After review, given this fault, it is likely that the generator battery will rebound to an expected battery level.A miscalculation within the generator's battery longevity algorithm resulted in an inaccurate battery status indicator.This record will be updated once the generator's battery life has been confirmed to have rebounded.No malfunctions are occurring within the generator.

Event Description

Contrary to prior supplemental mdr submitted for this event; the event will be considered to be afflicted by the software error as previously mentioned.This event is likely afflicted by the event and no other root cause is considered at this time.In the event that the battery does not rebound- this event will be re-investigated and new report submitted accordingly.

Event Description

It was reported that the device deficiency had resolved.No other 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17049767
• MDR Text Key: 316425453
• Report Number: 1644487-2023-00706
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2024
• Device Model Number: 8103
• Device Lot Number: 7291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/02/2023; 06/23/2023; 06/23/2023; 02/06/2024
• Supplement Dates FDA Received: 06/22/2023; 07/18/2023; 07/25/2023; 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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 Age: 73 YR
• Patient Sex: Female