MAUDE Adverse Event Report: CYBERONICS, INC. PERENNIAFLEX; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 304

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2017

Event Type  malfunction  

Event Description

The surgeon was about to place the lead and noticed it was mis-shaped and defective.The surgeon chose to not place the lead into patient due to these concerns.

• Brand Name: PERENNIAFLEX
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 6489672
• MDR Text Key: 72694494
• Report Number: 6489672
• 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
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/11/2020
• Device Model Number: 304
• Device Catalogue Number: 304
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• 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