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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 07/01/2012
Event Type  Injury  
Event Description

On (b)(6) 2013 clinic notes dated (b)(6) 2013, were received which indicated that the vns patient was admitted to the emergency room on (b)(6) 2013, due to a new seizures type and a new right arm weakness. On the night prior, the patient felt a sudden jerking of her right leg which came up off the bed, followed by her right arm which was shaking as well. The patient stated that it reminded her of a grand mal seizure which she had at age (b)(6), which was unusual for her. The patient's arm became numb, and this was a different seizure, so they wanted to admit the patient after having a head ct which showed abnormalities, nothing acute. The plan was to admit her, and do a video eeg there, thinking that these may be different seizures. It was decided to transfer her, in order to rule out the possibility of stroke, which was doubtful (as this was thought to be a todd's paralysis based on her (b)(6) hmri) but just to make sure there was nothing else going on. By the morning the patient regained her strength in the right hand, suggesting that this was postictal todd's paralysis as suspected. The clinic notes mention that due to the fact that she has been in the er with seizures lately, the last week, and a few other times in the er for other seizures, it may be that she is having a combination of epilespy but also none-epileptic seizures. Clinic notes dated (b)(6) 2013, indicate that the vns battery is at end of service and that before (b)(6) 2012 the patient seizures were picking up, but since (b)(6) 2012, she has had a lot more seizures that are bigger; averaging 2-6 convulsions per month. It was stated that the vns is giving her a little bit of shortness of breath now and then, although she says the symptoms are tolerable. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. A blc was performed which showed 6. 4 years remaining until eri=yes. Good faith attempts for further information from the physician were unsuccessful.

 
Event Description

An implant card was received which indicates that the vns device was explanted on (b)(6) 2013.

 
Event Description

The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.

 
Manufacturer Narrative

 
Manufacturer Narrative

Describe event or problem, corrected data: supplemental report #1 did not indicate that the device will not be explanted due to the hospital's privacy policy. The information has been included in this report.

 
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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 Key3065662
Report Number1644487-2013-01052
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/26/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014416
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2005
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: 04/18/2013 Patient Sequence Number: 1
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