MAUDE Adverse Event Report: CYBERONICS, INC. VNS THERAPY® MODEL 302 LEAD; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 302-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/05/2017

Event Type  malfunction  

Event Description

Patient scheduled for surgery early (b)(6) due to lead discontinuity - for replacement.

Manufacturer Narrative

Unique device identifier (udi): for type of device: stimulator, autonomic nerve, implanted for epilepsy.

Event Description

Patient scheduled for surgery early july due to lead discontinuity - for replacement.

• Brand Name: VNS THERAPY® MODEL 302 LEAD
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 6739963
• MDR Text Key: 80911541
• Report Number: 6739963
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 302-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NONE STATED.
• Patient Age: 25 YR