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

Model Number 102

Device Problem Failure to Interrogate (1332)

Patient Problem Depression (2361)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

An implant card from the hospital reported that the patient had generator replacement on (b)(6) 2014 due to end of service.It also reported that the device was unable to interrogate due to battery depletion.The explant hospital does not return explanted devices per hospital policy.Therefore, the analysis is unable to be performed.

Event Description

It was reported that the patient's generator was unable to be interrogated.It was reported that patient has benefitted from vns therapy significantly.Additionally, it was reported that the patient's depression has been increasing.Good faith attempts for additional relevant information have been unsuccessful to date.Although surgery is likely, surgical intervention has not occurred to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4286715
• MDR Text Key: 5171912
• Report Number: 1644487-2014-03172
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2007
• Device Model Number: 102
• Device Lot Number: 012830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR