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

Model Number 102

Device Problem Difficult to Interrogate (1331)

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

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2015 that the patient recently had orthopedic surgery on her right shoulder.The surgery took place roughly two weeks ago and the patient¿s device was de-activated with a magnet for the duration of the procedure.Since then the patient has reported an increase in depression noted to be less than the pre-vns baseline, she has not been able to perceive stimulation, and the physician has been unable to interrogate her device.The programming system was reported to be functioning properly.The patient was referred for generator replacement.Although surgery is likely, it has not occurred to date.Good faith attempts for further information from the orthopedic surgeon have been unsuccessful.

Event Description

On (b)(6) 2015 clinic notes were received for review.Clinic notes dated (b)(6) 2015 indicate that the device could not be interrogated.The patient was noted to have a partial relapse in her ¿mdd¿, major depressive disorder.Clinic notes dated (b)(6) 2015 indicate that the patient has not felt stimulation over the past several days and is feeling worse with major depressive disorder (mdd) in full relapse.

Event Description

The patient underwent generator replacement surgery due to battery depletion; unable to interrogate.The explanted generator has been requested to be returned; however, it has not been received to date.

Event Description

Analysis of the generator was completed on 06/18/2015.The generator battery was found depleted as a result of normal, expected battery depletion based on the battery life calculation.The device performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative

• 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: 4465014
• MDR Text Key: 5323935
• Report Number: 1644487-2015-03707
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2015

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: 06/30/2008
• Device Model Number: 102
• Device Lot Number: 016030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 01/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/04/2015; 05/21/2015; 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2006
• 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 Age: 70 YR