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

Model Number 1000

Device Problems High impedance (1291); Battery Problem: High Impedance (2947)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported that patient had undergone battery replacement.During pre-op the impedance was okay.The battery was then replaced and high impedance was seen.The pin was noted to be re-inserted 3 separate times and the high impedance was not resolved.Test resistor was used in which high impedance was still seen.A new generator was implanted in which the diagnostics were seen to be okay.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 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

The explanted generator was received by the manufacturer and underwent product analysis in which no anomalies were identified.There were no performance, or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected information ; previous mdr inadvertently omitted information known prior to submission.D9.Device available for evaluation; previous mdr inadvertently omitted information known prior to submission.

Event Description

The device has been reported to be in the mail, in transit for the manufacturer.The device has not been received to date.No x-rays are available for review.Product/patient information has become available.No other relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected information ; supplemental mdr inadvertently omitted information known prior to submission d4.Product information; corrected information; supplemental mdr did not include product information for generator known prior to submission- mfr.Date: 20-jun-2022, expiration date: (b)(6) 2024, lot# 205814.This will not be populated on d4, as the information from the lead needed to be entered into these fields as there was a suspect product updated (generator --->lead).D6a & d6b.6a.If implanted, give date & 6a.If explanted, give date ; corrected information; supplemental mdr included information regarding generator.The suspect product has been changed and therefore so has the information for d6a & d6b.F10.Adverse event problem; corrected information; supplemental mdr included information regarding generator.The suspect product has been changed and therefore so has the information for f10 h6.Adverse event problem codes ; corrected information; supplemental mdr included information regarding generator.The suspect product has been changed and therefore so has the information for h6.

Event Description

After a review of all available data, it was determined that this event is likely related to a malfunction of the lead; rather than a malfunction of the generator as previously reported.The device history records of the generator were reviewed.The lead passed final quality and functional specifications prior to release.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: 16015172
• MDR Text Key: 306337224
• Report Number: 1644487-2022-01649
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2023

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 Model Number: 1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 02/14/2023; 07/31/2023
• Supplement Dates FDA Received: 01/16/2023; 02/22/2023; 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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