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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 06/01/2014
Event Type  Malfunction  
Event Description

It was reported that the patient was unable to turn off the vns with any of the magnets she has. The vns was later disabled. The patient reported that she tried to disable her generator because of severe pain at the time of stimulation. She has had the magnets since 2006, when she was first implanted. The physician turned the 2. 5ma down to output of 2. 25ma, then 2. 0ma, 1. 75ma, and then 0ma and back to 0. 25ma. The planned intervention is for the patient to undergo a generator replacement surgery. The physician stated that the magnet did cause/trigger violent coughing episodes upon application. System diagnostics were performed and no abnormalities were noted and the device was not near eos. No causal or contributory programming changes preceded the onset of the painful stimulation. The surgery was planned to preclude a serious injury, per the physician. The physician further stated that the patient¿s magnet mode stimulation is always off unless it is ¿spontaneously switching¿. The patient later clarified that she had begun to experience painful stimulation when she received her original implant in (b)(6) 2006. The anatomical location of the painful stimulation comes from the vagus nerve, up and down her neck, during stimulation. There has been no trauma to the left side or the vagus nerve. The patient has been using new magnets that she received a few weeks ago. The physician stated that he could not provide clarification on his statement that the device may be ¿spontaneously switching¿; he stated that he has never activated magnet current and no other physician programs the device. He stated that the ¿device is faulty no matter what¿. The physician indicated that the patient was slowly titrated up after implant in order to allow for accommodation to the stimulation. The physician later stated that the patient underwent a cervical rhizotomy soon after the issue began with the generator. The patient stated that she always has had pain with stimulation. She said it is at a low level and has never bothered her. She stated that her current generator has caused her different side effects than with her previous ones. The physician interrogated it at every visit to make sure the generator is functioning at the levels, he has set. She stated that at the end of (b)(6) 204, she suddenly had intense pain. She immediately put the magnet in place and instantly began to cough violently and her throat constricted so much she couldn¿t breathe. The physician set up an emergency visit for her to see him and at that visit she demonstrated what happened when she put the magnet in place over the generator. She again when into a violent coughing attack and her throat constricted as it had when she tried to use it in june. The physician quickly lowered the current down and got the same response. After doing so, a couple of times, he turned the generator off completely. After a bit, he turned the generator back on to 0. 25ma. The physician instructed her to put the magnet in place as he increased the output to 0. 25ma and interrogated it at the same time. The magnet worked normally and the diagnostics of the generator showed it functioning normally as well. The patient clarified that she is fully aware how to use the magnet. The patient stated that before the event in june she had just seen her physician two weeks prior, when her device was interrogated, and the physician did not change anything at that visit. The patient underwent generator replacement on (b)(6) 2014. The explanted generator has not been returned for product analysis to date.

 
Event Description

On (b)(6) 2014 the physician reported that the patient has not yet tried the magnet with her new generator but that they will test it at the next visit.

 
Event Description

The patient's magnet was tested with the new generator, and the physician reported that it was working well. It is also noted that the as-received explanted generator frequency parameter was set to 1hz. Per manufacturer labeling, frequencies programmed to <10hz do not ramp and cause excessive battery drain regardless of output current.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported the incorrect date.

 
Event Description

On (b)(4) 2014 the explanted generator was returned for product analysis. Product analysis was completed on the generator on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, 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. No magnet parameters (as received or programming history) available for this generator, magnet current was set to 0. 50ma. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported allegations against the generator were not duplicated in the product analysis lab. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key4036475
Report Number1644487-2014-02097
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 07/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number103
Device LOT Number202415
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/26/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/26/2014 Patient Sequence Number: 1
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