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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 08/27/2003
Event Type  Injury  
Event Description

It was reported by the vns patient that she has not had a seizure in a "very long time" but has been having chronic gastritis for years. She indicated that her gastroenterologist suggested she have her vns disabled and explanted. The gastritis was reportedly not attributed to vns however the physician indicated that it might impede improvement with digestion. The patient indicated that her heart rate has increased with stimulation since her vns was first turned on. The patient stated this takes her breath away and the increased heart rate was observed on an ekg. The patient indicated that she has not had her vns checked in a long time. The patient indicated that the vns has been beneficial so she would like to avoid turning the vns off but may pursue vns disablement if it is necessary to help resolve the digestion issues. The patient also indicated that her generator may have migrated due to weight loss and her chest is now more uncomfortable as a result. She indicated that she also sleeps on the same side as her generator is implanted on and that may be contributing to the discomfort. The patient is considering having her vns disabled and/or removed however she had not discussed with a physician. Attempts for follow-up have been unsuccessful to date. Although the patient indicated she may be pursuing intervention, no interventions appear to be planned at this time.

 
Event Description

It was reported that the patient wants to have the device explanted due to gastric issues. It was reported that the patient has lost 70 pounds and it is still being considered that the vns could be the cause of the gastric issues which resulted in the weight loss. It was reported that the surgery would be for patient comfort and not to preclude a serious injury. No surgical intervention has been performed to date.

 
Event Description

Additional information was received that the patient had their generator turned off and that the patient was having the vns system explanted due to needed mri for osteo-arthritis. The imaging center will not do the mri with the system implanted. Another call was received the same day that stated that due to the other issue the patient has had with vns the patient would not be re-implanted.

 
Manufacturer Narrative

 
Event Description

Additional information was received that the patient was explanted. The hospital required as sign authorization to have the explants sent to the manufacturer for evaluation, so the lead and generator will not be returned to the manufacturer for evaluation.

 
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Brand NamePULSE GEN MODEL 102
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 Key2682077
Report Number1644487-2012-01947
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 07/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/15/2009
Device MODEL Number102
Device LOT Number017112
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2007
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: 08/04/2012 Patient Sequence Number: 1
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