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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 11/01/2011
Event Type  Injury  
Event Description

Clinic notes were received for review from a patient office visit dated (b)(6) 2012. The vns patient does not remember all of her seizures and believes that they have not increased in frequency. Her husband believes her seizures have been increasing in frequency over the last few months. He also reports she is now having seizures that start as staring spells and did not have these prevns. The patient's vns was interrogated and set at 1. 75/500/30/30/5 magnet 2/500/60. Normal mode diagnostic testing showed at dcdc 5 and system diagnostic results of dcdc 2 eri no. However, according to her husband, the patient has been having an increase in seizure activity over the last few months. He also notes she is having seizures that start as staring episodes, and then she will fall. He states, she has not had these types of event since prior to her vns implantation. Therefore, it appears that the vns is likely nearing eos and today she will be referred for battery change. No surgery is scheduled at this time. On (b)(6) 2011, the patient was admitted to hospital for 2 weeks due to psychosis. Device function was confirmed. The patient has a history of major depression/catatonia. Good faith attempts have been made for further details about the reported event and thus far no further information has been attained.

 
Event Description

The patient had their generator replaced on (b)(6) 2012. The explanted generator is being returned for analysis. Additional information was received. It is unknown when the patient's seizure event first started. She has poor memory. Their dcdc was a 5 so referred for a battery change. Unknown if their seizure frequency was above their prevns level as not documented. The patient's last medication change was on (b)(6) 2011 an increase in keppra. It is unclear the relationship of their psychosis to their vns.

 
Event Description

The patient had a prophylactic generator replacement. The generator is at the manufacture pending completion of product analysis.

 
Event Description

Analysis was completed on the patient's generator. In the 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. 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. There were no performance or any other type of adverse conditions found with the pulse generator. The patient's implant card reported their generator was replaced for prophylactic reasons.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2434874
Report Number1644487-2012-00246
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014277
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date04/16/2012
Event Location Other
Date Manufacturer Received04/16/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/13/2005
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: 02/01/2012 Patient Sequence Number: 1
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