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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/02/2016

Event Type  malfunction  

Event Description

It was reported by a surgeon's office that a vns depression patient was not sure her generator is working as well.The device was reported not to be at end-of-service and system diagnostics were reportedly okay.An estimate of battery life calculation indicated 3.3 years until near end-of-service.Additional relevant information has not been received to-date.

Event Description

Additional information as received from the physician that clarified that there is now no concern with the generator.The patient was experiencing pain with stimulation but resolved with the current turned down from 2.0ma to 1.75ma.At 2.0ma previously, the patient experienced a tugging sensation.He reported that the patient's depression is improved due to vns.

Manufacturer Narrative

The event is a product problem.There is no indication of a serious injury or the patient requiring intervention to prevent a serious injury.The initial report inadvertently reported this information incorrectly.Since the event has been determined to be a product problem (see above) there is no outcome to be selected.The initial report inadvertently reported this information incorrectly.

• 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: 5537887
• MDR Text Key: 41550780
• Report Number: 1644487-2016-00679
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2016

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: 08/31/2007
• Device Model Number: 102
• Device Lot Number: 014097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2016; 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2005
• 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): Other
• Patient Age: 60 YR