MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

Model Number 103

Event Date 07/14/2011

Event Type  Injury  

Manufacturer Narrative

Event Description

Reporter indicated a patient was having increased seizures that were felt to be due to a depleting vns generator, even though the generator was not at end of service. The generator was replaced prophylactically due to anticipation of a near end of service condition. The patient later had generator replacement surgery performed. The explanted generator has been returned and is pending analysis. Attempts for further information are in progress.

Event Description

Product analysis of the vns generator was completed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. All attempts to the reporter for further information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: PULSE GEN MODEL 103
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS INC; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd; suite 600; houston , TX 77058 ; 2812287200
• MDR Report Key: 2251858
• Report Number: 1644487-2011-02195
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/16/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 06/30/2010
• Device MODEL Number: 103
• Device LOT Number: 2151
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/25/2011
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/23/2011
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 08/11/2008
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 09/16/2011 Patient Sequence Number: 1