MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

Model Number 103

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2013 noted that the patient has a past surgical history of cardiac surgery. It is unknown if the cardiac surgery occurred prior to vns therapy or the relationship to vns therapy. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS INC; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston , TX 77058 ; 2812287200
• MDR Report Key: 3301479
• Report Number: 1644487-2013-02478
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/26/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/21/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 12/31/2011
• Device MODEL Number: 103
• Device LOT Number: 2637
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/26/2013
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/15/2010
• 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: 08/21/2013 Patient Sequence Number: 1