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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 06/03/2011
Event Type  Injury  
Event Description

Additional information was received that the office could not address the questions and request for additional information.

 
Manufacturer Narrative

Corrected data: the initial report inadvertently had the incorrect explant date.

 
Event Description

It was initially reported that the patient was experiencing an increase in seizures, unknown if above or below baseline. The increase in seizures was believed to be related to the generator being at end of service. The patient had their generator replaced and it was returned to the manufacturer for evaluation. The generator was found to not be at end of service so the cause of the increase in seizures is unclear. The end of service allegation was not confirmed in the product analysis lab. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Analysis of the generator in the product analysis lab concluded that there was no adverse performance condition found with the generator. Good faith attempts for more information have been unsuccessful to date.

 
Event Description

Additional information was received as clinic notes dated (b)(6) 2012, that indicate the patient has had no more drops and 3 gtcs in the past month. It is not indicated if this is an increase or decrease from the patient's normal seizure behavior and it is unknown if the seizures have resolved following replacement. The notes also indicated the patient had not been at intended settings since (b)(6) 2012, due to a faulted diagnostics test which has been reported in manufacturer report # 1644487-2012-01639. It was also noted that the patient's sleep apnea is not being treated which was previously reported in manufacturer report # 1644487-2011-01491. Diagnostics taken were normal per the clinic notes.

 
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Brand NamePULSE GEN MODEL 101
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 Key2270410
Report Number1644487-2011-02321
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 09/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2003
Device MODEL Number101
Device LOT Number4039
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/29/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/05/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/05/2001
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: 09/30/2011 Patient Sequence Number: 1
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