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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 10/06/2014
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient believed something was wrong with her lead during an office visit on (b)(6) 2014. The patient was experiencing neck pain, so the physician subsequently lowered the patient¿s device settings. During an office visit on (b)(6) 2014, the patient¿s device was tested and diagnostic results showed normal device function. The patient had a seizure in the office in which she was unresponsive and leaning her head back and forth with her eyes closed. No shaking or rhythmic movement was noted. The magnet was used and the seizure lasted approximately three minutes. The patient opened her eyes but was unresponsive for several minutes. The patient was unaware of the seizure. Since her last office visit on (b)(6) 2014, the patient had eight gtc seizures and had been to the er twice. The physician was questioning the battery status of the patient¿s device. A battery life calculation using the available programming history showed approximately three years remaining until neos = yes. The patient underwent generator replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
Event Description

Additional information was received stating that the vns patient¿s increase in seizures was due to the decrease in device settings.

 
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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 Key4377886
Report Number1644487-2015-03513
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number102
Device LOT Number201423
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/13/2010
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: 01/02/2015 Patient Sequence Number: 1
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