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

Model Number 102

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient was admitted to the hospital due to increasing depression and anxiety, because the vns battery died.The patient was referred for surgery; however, insurance coverage was denied.Insurance coverage is being pursued; however, no surgical intervention has occurred to date.

Event Description

An implant card was received indicating that the patient underwent generator replacement.The explanted generator was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on 09/24/2014.The analysis found that the device had reached an end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted.The low battery voltage condition (depleted) was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.The device performed according to functional specifications.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

Event Description

Clinic notes dated (b)(6) 2014 indicate that the patient is worried about the vns not working.The notes indicate that vns battery not functional.Attempts to obtain additional relevant information have been unsuccessful 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: 3815726
• MDR Text Key: 4602043
• Report Number: 1644487-2014-01297
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2007
• Device Model Number: 102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 05/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2014; 07/22/2014; 09/19/2014; 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 46 YR