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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 08/20/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time.

 
Event Description

Additional information was received on (b)(6) 2013 when it was reported that the vns patient has lost 40 pounds and is vomiting. The patient's device was shut off except for the magnet settings. The physician questioned whether the leads could possibly be placed upside down. The patient was stated to have profuse vomiting when the device is on. It was reported that the patient's device has sporadically been on and off based on the patient's vomiting events. Currently the physician is thinking about turning the magnet mode off as well.

 
Event Description

It was again reported that since his vns implant, the patient has had serious stomach issues and has lost a considerable amount of weight. The patient, however, has had an improvement in seizure reduction. The patient was noted to have had persistent vomiting, changes in appetite, and weight loss.

 
Event Description

Additional information was received on (b)(6) 2013, when it was reported that the patient had the vns device turned off over a month ago by the surgeon because of vomiting. There are no plans to turn it on until the patient sees a gastro physician.

 
Event Description

On (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time.

 
Manufacturer Narrative

Describe event or problem; corrected data: inadvertently stated "on (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time" instead of "on (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time" on supplemental report #1.

 
Event Description

Additional information was received on (b)(4) 2013 when it was reported that the patient had a follow-up visit with her nurse practitioner that day. The first interrogation of the device indicated that the device was "off, the output current was 0. 0ma, however the magnet output current was at 0. 25ma. The vomiting has "slowed up some" since (b)(6) 2012 and the patient has lost 40 pounds and has little appetite. There were 3,746 magnet activations captured on the device. The device was then programmed "on" to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 5ma/magnet pulse width=500usec/magnet on time=60sec. System diagnostics were "ok" and the ohms was noted to be 3,580ohms.

 
Event Description

It was reported that shortly after the patient's vns stimulation was enabled immediately following initial vns implant surgery, the patient began vomiting. The physician indicated that he was unsure if the vomiting was occurring with stimulation, but he indicated it was likely. The patient was noted as not vomiting when the family swipes the magnet over the generator to activate extra stimulation to abort a seizure. The patient's family believes the patient is having a sensation in his stomach however the patient is nonverbal. The patient's vns was disabled for 3-4 days however when the stimulation was re-enabled, the patient was vomiting so much he became dehydrated and had an increase in seizures requiring hospitalization as a result. Vns diagnostics had not been run since surgery which were noted as within normal limits at that time. The patient's vns has been turned back off for the time being. Follow-up with the patient's neurologist found the patient has a dental abscess which she and the surgeon believe may be contributing to the vomiting with stimulation. They have asked the patient to have resolved and then they will resume vns stimulation. No medication changes were believed to have caused or contributed to the events. Attempts for the missing product information are in progress.

 
Manufacturer Narrative

 
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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 Key2766219
Report Number1644487-2012-02473
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/30/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number103
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/01/2012 Patient Sequence Number: 1
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