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

Model Number 102

Device Problem Programming Issue (3014)

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

Event Date 12/02/2014

Event Type  malfunction  

Event Description

Clinic notes were received indicating that the vns patient¿s device had been disabled in (b)(6) 2008 due to painful stimulation.It was reported that during an office visit on (b)(6) 2014, the physician was considering programming the device back on due to the patient¿s condition, but was unable to interrogate the patient¿s device despite using two known working programming systems.No known surgical interventions have occurred to date.

Event Description

It was reported that no further attempts have been made to interrogate the patient's device.Insurance coverage is being obtained for revision surgery.The patient experienced returns of suicidal thoughts which was reported to be related to the progression of the patient's depression.Suicidal ideations are not new for this patient and the return of the suicidal thoughts are unrelated to vns.

Manufacturer Narrative

Event Description

An implant card was received indicating that the device was still unable to interrogate at the replacement surgery.The reason for replacement was identified as "battery depletion, unable to interrogate due to battery depletion." the explanted generator has been received by the manufacturer.Analysis is underway , but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.The reported failure to program was determined to be the result of normal battery depletion.The depletion was an expected event as determined by battery life calculation and battery voltage measurement.The module performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Initial reporter: the incorrect contact information for the initial reporter was provided inadvertently.Relevant tests/laboratory data: the available device settings and estimate of battery life calculation were inadvertently not provided in the initial report.

Event Description

It was reported that the patient has had an increase in depression, and has made suicide attempts.Medication changes were considered.The patient had generator replacement surgery on (b)(6) 2015.The explanted product has not been received to-date.

• 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: 4369050
• MDR Text Key: 5234137
• Report Number: 1644487-2014-03474
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2007
• Device Model Number: 102
• Device Lot Number: 013118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/12/2015; 10/26/2015; 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2005
• 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 Age: 50 YR