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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Tingling (2171); Dysphasia (2195); Discomfort (2330)

Event Date 09/05/2015

Event Type  malfunction  

Event Description

It was reported that a patient was experiencing erratic stimulation constantly and tingling pain at neck/clavicle area.Diagnostics were performed and were within normal limits.The patient¿s generator was programmed off, but the pain persisted.The (b)(6) wants the device replaced due to the issue.The device remained programmed off.Per clinic notes from (b)(6) when the patient followed-up with her physician, the patient was seen in the hospital with pain in her neck and throat.The device stimulation caused ¿intense pain¿ in her throat.The patient was unable to speak and felt as if the device was ¿squeezing¿ her throat.After the device was programmed off, the patient reported that the squeezing sensation in her throat became ¿unacceptable stinging in the left neck¿.The magnet was taped to the patient in the hospital to stop the stimulation, but was unsuccessful.

Event Description

The patient had generator replacement on (b)(6) 2015 due to pain.The explanted device was received by the manufacturer.However, analysis has not been completed to date.

Event Description

Analysis was completed on the generator.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Information was later received that near the time of the initial event, the patient was undergoing a procedure unrelated to vns when an anesthesiologist noticed some spots on her throat and referred her to an ent physician.The patient saw the ent physician sometime near (b)(6) 2015 and noticed that her vocal cords were not opening or closing like they were supposed to.Patient did not have any symptoms from this event.The ent physician did not take any intervention for this and told patient to come back in 6 months for a checkup.Additional relevant information 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: 5118141
• MDR Text Key: 27545407
• Report Number: 1644487-2015-05966
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 09/05/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2010
• Device Model Number: 102
• Device Lot Number: 200975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/03/2015; 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2008
• 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: 48 YR