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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 09/01/2014
Event Type  Injury  
Event Description

Clinic notes were received for review which were dated (b)(4) 2014 and indicated that the patient was having painful stimulation from her vns. Normal mode diagnostics showed a dcdc of 4. The patient was also experiencing an increase in seizures frequency since the patient¿s last visit. The patient was observed in the clinic without any signs of pain or intolerance associated with her settings. The patient was noted to now be experiencing baseline seizure frequency. The physician indicated that since te patient is experiencing an increase in seizures and in (b)(6) 2014 reported isolated painful stimulation, this suggests her current battery is nearing end of service although the battery has not flagged ifi=yes. Therefore the patient was referred for surgery. Clinic notes dated (b)(4) 2014 were also received which indicated that the patient has been experiencing an increase in auras, not progressing into seizures at that time. The patient¿s normal mode diagnostics had increased to a dcdc of 4 and the patient was noted to be experiencing sporadic isolated painful stimulation. The physician indicated that due to the sporadic painful stimulation that started a couple of weeks prior and the diagnostics testing, she referred the patient for generator replacement. Clinic noted dated 06/06/2014 also indicate an increase in auras not progressing into seizures. Although surgery is likely, it has not occurred to date.

 
Event Description

It was reported that the patient underwent prophylactic generator replacement on (b)(6) 2015. The physician¿s assistant attributed the patient¿s increase in seizures to the device nearing end of service, per the battery life calculation on the generator. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. It was noted that the patient hasn¿t been seen by the physician¿s assistant since the generator replacement. The patient¿s generator was discarded after surgery by the hospital and therefore cannot be returned for product analysis.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102R
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 Key4401771
Report Number1644487-2015-03576
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 12/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2010
Device MODEL Number102R
Device LOT Number200929
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2008
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: 01/09/2015 Patient Sequence Number: 1
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