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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 05/16/2012
Event Type  Malfunction  
Event Description

Additional information was received on (b)(6) 2012. It was indicated that the initial reporter had not seen the patient back as she was only there for a follow up for a brain tumor that she had prior to being implanted. Per the reporter, she was the one who was attempting to interrogate the patient and she got "nothing" from the device and they were unable to perform the mri. She indicated that they are having no problems at all with their programming system and that it is functioning as intended. They have not seen the patient again as she only follows up every year or so only for this mri. Follow up was then performed with the patient's treating neurologist, who indicated that the device was last interrogated in (b)(6) 2010. She did indicate that the patient was seen again in (b)(6) 2012. Interrogation was not attempted at that time, however she felt that the vns was working as the patient was still experiencing cyclical voice alterations with stimulation. The neurologist indicated that she feels the generator has reached end of service and that is the reason that it could not be communicated with. No additional information was provided.

 
Event Description

It was reported by an mri technician that while trying to disable the device, they were receiving a failure to communicate message and were unable to interrogate the generator. Multiple programming systems were used and troubleshooting steps, including checking the wand battery and making sure that the programming system was unplugged from the wall were performed, however, the device could not be interrogated. The patient indicated at the time that she was unsure of the last time her device was checked stating that it may have been in 2009. A rough estimation of battery life was calculated based on available programming history which indicated that the device may be at or nearing end of service. However, end of service has not been confirmed.

 
Manufacturer Narrative

 
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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 Key2614735
Report Number1644487-2012-01493
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number102
Device LOT Number011003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/03/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/24/2004
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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