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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 10/15/2013
Event Type  Injury  
Event Description

Generator analysis was approved on (b)(6) 2013. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. The reported ¿failure to program¿ allegation was duplicated (not due to eos) in the pa laboratory at two orientations. Repositioning the wand resolved, and this it is not considered a device malfunction. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

On (b)(6) 2013, this vns patient underwent prophylactic generator revision. The patient reported an increase in seizures, and the patient¿s neurologist was not able to interrogate the device. The device was believed to be at end of service, and the patient was referred for surgery. The patient had gained weight. The device could be programmed and interrogated successfully on the date of explant. Follow-up showed that the device was changed because it had migrated into the axilla. The device couldn't be interrogated due to the patient's habitus, and she could not tolerate prolonged searching secondary to her psychiatric problems. The most recent settings as of (b)(6) 2013 were provided. The physician stated that the failure to program occurred on (b)(6) "2031", and the physician was unable to do a normal mode test. This would not process. The vns was also very slow to interrogate. This was possibly caused by physical location of the vns. The generator was returned on (b)(6) 2013 and is pending analysis. An in-house battery life calculation showed 5. 63 years remaining.

 
Manufacturer Narrative

Analysis of programming history.

 
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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 Key3488430
Report Number1644487-2013-03617
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number102
Device LOT Number201051
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/03/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/19/2009
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: 11/25/2013 Patient Sequence Number: 1
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