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 02/01/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced a decline in mood and the generator was reported to be "good".The physician was considering generator replacement.Clinic notes dated (b)(6) 2015 note that the patient feels that the vns device may need adjustment and that the patient reported experiencing a significant increase in his depressive symptoms progressively over the past two months.Attempts to obtain additional relevant information have been unsuccessful to date.No known surgical interventions have been performed to date.

Event Description

The physician reported that the patient would undergo generator replacement due to end of service.No known surgical interventions have been performed to date.

Manufacturer Narrative

Event Description

It was reported that the patient underwent generator replacement.Device diagnostics performed prior to replacement were within normal limits (eos - no).Device diagnostics with the new generator attached to the existing lead were within normal limits.The explanting facility retained the explant; therefore, analysis is not possible.The implant card indicated that the generator replacement was prophylactic.

• 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: 4788153
• MDR Text Key: 5819942
• Report Number: 1644487-2015-04755
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2007
• Device Model Number: 102
• Device Lot Number: 014097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2005
• 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: 71 YR