MAUDE Adverse Event Report: CYBERONICS, INC. / LIVANOVA USA, INC ASPIRE SR MODEL 106 GENERATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

Procedure was removal and replacement of vagal nerve stimulator on (b)(6) 2022.The patient¿s surgical history consisted of a surgery was done in germany, to have shrapnel taken out, due to being hit by ied in iraq, it was reported that since then seizures started.Pre and post-op diagnosis was seizure disorder, intractable (hc code).The explanted vagal nerve stimulator was sent in with no device/therapy allegation report with the returned product.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ASPIRE SR MODEL 106 GENERATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): CYBERONICS, INC. / LIVANOVA USA, INC
• MDR Report Key: 17875968
• MDR Text Key: 325227450
• Report Number: MW5146569
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/03/2023

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 Expiration Date: 02/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• Patient Sequence Number: 1