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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 01/24/2013
Event Type  Malfunction  
Event Description

Reporter indicated via clinic notes dated (b)(6) 2013 received to the manufacture that a patient was having recent increased seizures. The patient was admitted to the hospital after two weeks of pneumonia. Medication was increased as an intervention. Prophylactic replacement of the vns generator is possible. Attempts for additional information are in progress.

 
Event Description

Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. The physician reported that the increase in seizures were below the patient's pre-vns baseline frequency. It was reported that the patient was hospitalized in the icu due to respiratory problems at the time of the increase in seizures. The physician did not feel that vns played a role in the increased seizures. Attempts to have the device returned for analysis have been unsuccessful to date.

 
Event Description

The explanted generator was returned to the manufacturer. 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 690 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows an ifi condition. The data in the diagaccum consumed memory locations revealed that 107. 632% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. However, a review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy. This error results in an incorrect device longevity estimate. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 104
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 Key3109902
Report Number1644487-2013-01356
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2009
Device MODEL Number104
Device LOT Number16869
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/14/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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