MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 102

Model Number 102

Event Date 07/28/2009

Event Type  Injury   Patient Outcome  Required Intervention

Event Description

Reporter indicated a vns therapy pt "decided to remove the battery himself. He literally removed the battery including the leads", and the incision became infected. The physician did not know the pt removed the vns therapy system. The pt's family reports the pt "has been doing strange things", since his medications were changed. Mfr records confirmed device sterility prior to shipment. The explanted vns therapy system has been returned to the mfr and is pending analysis. Good faith attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative

Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd., ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 1528647
• MDR Report Key: 1463630
• Event Key: 1349302
• Report Number: 1644487-2009-01858
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2009

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/28/2009
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 07/31/2010
• Device MODEL Number: 102
• Device LOT Number: 200961
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2009
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 07/30/2009
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 12/01/2008
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Initial