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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 01/01/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 indicate that the patient has been experiencing a new type of seizure that is different than the patient's usual staring episodes. It was noted that the new events are more of confusional episodes, and have been occurring approximately 3 times per week. It was noted that the patient does not have any evident seizures prior to the confusional episodes. It was noted that the patient's mother describes the patient's eyes as glazed over and he is unresponsive for a few minutes. Following the episodes, the patient has a headache and may be agitated. The patient was referred for generator replacement. The patient underwent generator replacement on (b)(6) 2013. The generator was returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not yet been completed to date.

 
Event Description

The generator analysis was completed on (b)(6) 2013. In the pa 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. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Further follow-up revealed that overall, the patient has been doing reasonably well after the generator replacement.

 
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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 Key3336683
Report Number1644487-2013-02633
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015790
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/29/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/18/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2006
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: 09/09/2013 Patient Sequence Number: 1
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