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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 01/29/2015
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2015 reported status epilepticus was on the new problem list. The chief complaint was seizures with dead vns battery. The patient moved residences the week prior and had her first seizure in a while. The physician assessed that the patient experienced recurrent seizures since. Additionally, it was noted that some of her medications were previously discontinued by the previously treating physician. The patient¿s generator was unable to be interrogated due to suspected end of service by the physician. The physician reported in the notes that the patient is sensitive to the vns and reports having seizure when being tested. The patient developed complex partial status epilepticus in the clinic. The patient was transferred to the medical care center. No known surgical intervention has occurred to date. Good faith attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received from the treating physician¿s office. It was reported that they have not had any vns programming system issues since the patient's device could not be interrogated. They elected to refer the patient for generator replacement surgery due to battery depletion and prophylactic lead replacement. No known surgical intervention has occurred to date.

 
Event Description

Additional information reported that the patient was scheduled for generator replacement due to the device not working. Generator replacement occurred on (b)(6) 2015. It was reported that the explanted device could be interrogated pre-operatively. It was reported to not be at end of service condition and diagnostics were within normal limits (dcdc-2). The lead was not replaced. The explanted generator has not been received by the manufacturer for analysis to date.

 
Event Description

The explanted generator was received for analysis. However, analysis has not been completed to date. The reason for replacement was reported to be prophylactic n the return paperwork.

 
Event Description

Analysis of the generator was completed. The reported failure to program was duplicated (not due to end of service of the battery) in the analysis laboratory at two orientations. This is addressed in the vns physicians manual by instructing the user to reposition the wand. Since product labeling addresses these situations and provides instructions to easily remedy the events (wand position and system operation), it is not considered a device malfunction. 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 generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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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 Key4621721
Report Number1644487-2015-04192
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number102R
Device LOT Number2064
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/03/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/30/2006
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: 03/20/2015 Patient Sequence Number: 1
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