MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Nerve Damage (1979); Paresis (1998)

Event Date 01/25/2019

Event Type  Injury  

Event Description

It was reported on vns therapy (b)(6) by a patient¿s mother that her son had vagus nerve damage that caused gastro paresis as a side effect of vns therapy.No patient could be identified, and no further information was received despite reaching out to the reporter.No additional information is available.

Event Description

It was reported on vns therapy facebook page by a patient¿s mother that her son¿s eighth battery replacement damaged the vagus nerve, and now the only way he keeps food down is through anti-vomiting medications.Based on the number of replacements and timeframe, this report was found to be related to the vomiting and weight loss previously reported in mfr report #1644487-2019-00017.Any additional or relevant information related to this event will be reported under mfr report #1644487-2019-00017.

Event Description

It was reported on the vns therapy facebook page in a comment from the original reporter that the patient had experienced vomiting and weight loss due to gastroparesis.The patient¿s vomiting began the day after a battery replacement, and the patient has lost 25 pounds in less than three months.She did not say any intervention had taken place.The reporter alleged that the patient¿s vagal nerve became inflamed or damaged during the procedure.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8348620
• MDR Text Key: 136479324
• Report Number: 1644487-2019-00318
• Device Sequence Number: 1
• Product Code: LYJ
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2019
• Device Model Number: 106
• Device Catalogue Number: N/A
• Device Lot Number: 204169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• 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: 29 YR