MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Cough (4457)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that patients vns had an error message upon interrogation.When the device was interrogated on (b)(6) 2023, they got a message stating that the therapy had been disabled.Normal and magnet mode were still programmed at the correct settings but the heart rate detection was off.The physician reprogrammed the generator to previous settings but the patient started coughing a lot so the titration was started per new patient protocol.The patients settings and diagnostics from their previous visit was provided.Device history records were reviewed.The device passed all functional and quality testing prior to distribution.The coughing is concluded to be related to stimulation and is a known inherent risk of the device that is documented in labeling.No other relevant information has been received to date.

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 livanovas 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.Type of investigation: b20.

Event Description

The patient's device was seen with error code 6 again upon interrogation resulting in the generator being disabled with no therapy delivered.The physician decided not to resume therapy.It was later reported that the patient may not opt to have the device replaced.The patient has not been exposed to any unusual environment conditions.No other relevant information has been received to date.

Event Description

Programming history was received and a decoder spreadsheet was created and reviewed.Device reset was confirmed to have occurred on (b)(6) 2023.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 16532877
• MDR Text Key: 311225801
• Report Number: 1644487-2023-00298
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2023
• Device Model Number: 1000
• Device Lot Number: 205763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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
• Patient Age: 11 YR
• Patient Sex: Male