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

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient has noticed an increase in depression.The patient reported that vns has helped her gastroparesis, but that she began having some issues related to that.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

It was reported that the patient was seen by the physician at which time device diagnostics showed the device was at near end of service.The patient was referred for generator replacement.Clinic notes dated (b)(6) 2015 note that the patient needs a new generator and that she feels her depression is worse.Clinic notes dated (b)(6) 2014 note that the patient experiences occasional thoughts of suicide.No known surgical interventions have been performed to date.

Event Description

The patient underwent generator replacement surgery on (b)(6) 2015.The explanted generator has not been received to date.

Event Description

The explanted generator was received for analysis.The reason provided for the explant was battery depletion, unable to interrogate.Analysis of the explanted generator was completed on 08/17/2015.Open can measurement of the battery voltage determined that the battery was depleted.The end of service condition 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.

Event Description

The physician reported that the occasional thoughts of suicide mentioned in the (b)(6) 2014 notes were not related to vns.

• Brand Name: PULSE GEN MODEL 102
• 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: 4424136
• MDR Text Key: 5377374
• Report Number: 1644487-2015-03622
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2014

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: 11/30/2007
• Device Model Number: 102
• Device Lot Number: 014865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/26/2015; 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2006
• 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): Other
• Patient Age: 62 YR