MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Battery Problem (2885)

Patient Problem Depression (2361)

Event Type  malfunction  

Event Description

It was reported by the patient's wife that she believed the vns battery was depleted since the last appointment, in (b)(6) 2015, the vns was doing ok and the patient was doing well, but recently the patient went downhill and was hospitalized due to worsening depression.A battery life calculation showed that the generator had approximately 0 years remaining until neos = yes (near end of service).It was later reported by the patient's wife that they saw a physician in (b)(6) 2016 who said the vns battery was still working well.The patient's wife noted they would increase visits to the physician to be sure to know when the vns battery does reach eos (end of service) so that the generator can be replaced at that time.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5811874
• MDR Text Key: 50960312
• Report Number: 1644487-2016-01651
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2007
• Device Model Number: 102
• Device Lot Number: 014585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2005
• 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