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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 04/01/2012
Event Type  Injury  
Event Description

Follow up with the physician's office regarding the reported cyanosis with the patient's seizures prior to replacement. It was reported that the cyanosis is not believed to be related to vns therapy.

 
Event Description

Clinic notes dated (b)(6) 2012 revealed that the patient has experienced worsening seizures, and the caregiver reports that the vns magnet does not consistently work like it has in the past. The patient has lennox-gastaut syndrome and has intractable generalized tonic-clonic seizure activities. The notes revealed that the patient had these seizure activities about seven times a month. The patient also suffers from atonic, partial, and myoclonic seizures. However, the patient had recently been experiencing more seizures accompanied with behavioral issues. The patient's seizure diary revealed to the physician that she had increased frequency of seizures of both generalized tonic-clonic and "bloom" seizures. For the previous two months, the post-ictal state had been up to two hours. Her generalized tonic-clonic seizures appeared to be more severe, and she was sometimes having cyanotic lips during seizures. It was also mentioned that the "increase in seizure activities could be due to recent illness with upper respiratory infections and possible uti. " follow up with the referring physician revealed that the increase in seizures began in (b)(6) 2012 and was "likely due to low battery of vns. " no additional information was provided regarding the increased seizures and change in seizure pattern. The patient had prophylactic generator replacement surgery on (b)(6) 2012. The patient's device was programmed to the pre-operative settings following generator replacement, and post-operative diagnostics were within normal limits. The generator was received by the manufacturer for analysis on (b)(6) 2012. However, product analysis has not been completed to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Product analysis for the explanted generator was completed. 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 performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

 
Event Description

The return product form was received by the manufacturer which reported that the generator was replaced prophylactically on (b)(6) 2012. However, product analysis has not been completed to date.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2578417
Report Number1644487-2012-01235
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2009
Device MODEL Number102
Device LOT Number1970
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/16/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/25/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/20/2007
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: 05/17/2012 Patient Sequence Number: 1
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