MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Twitching (2172); Choking (2464)

Event Date 08/25/2009

Event Type  Injury  

Event Description

Initially, it was reported that the patient has experienced pain in the left jaw and teeth.The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth.The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging.The patient reported that there appears to be muscles twitching in his neck area.The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians.It was later reported that the patient would be referred to surgeon for full vns revision surgery.Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision.No additional relevant information has been received to date.No surgical intervention has been performed to date.

Event Description

It was reported that the patient underwent generator replacement.The lead was not replaced.Device diagnostics prior to and during surgery were within normal limits.It was reported that the explanting facility does not returned explanted devices for analysis.

Event Description

It was reported that the patient was turned up that day from 1.0ma to 1.25ma.Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again.It only lasted a little bit.The physician stated that the patient is having the same pain in the jaw with the new generator.The patient used to be set at 1.75ma, but now when they turn the current up to 1.25ma the patient experiences instant pain when the device turns on.He also states that after a few hours of normal operation the pain gets worse.Settings are output=1-1.25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin.Diagnostics are ok; impedance=2213ohms.The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.

Manufacturer Narrative

Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.

Event Description

Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014.The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option.During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down.Additionally, a tie-down had been placed on the electrode coil on the nerve.No other tie downs were observed.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description

On (b)(6) 2015 the patient reported that his vns has been turned off for about 5.5 months because of ¿several problems¿.It was later reported that the patient has had his device for a while due to painful stimulation.The patient will be proceeding with explant of the vns device.Although surgery is likely, it has not occurred to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 3845774
• MDR Text Key: 4657162
• Report Number: 1644487-2014-01399
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/06/2014

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: Health Professional
• Device Expiration Date: 03/31/2010
• Device Model Number: 302-20
• Device Lot Number: 7541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2014; 08/12/2014; 03/11/2015; 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2002
• 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: 47 YR