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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 05/08/2007
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported that the physician stated the patient¿s device has been disabled again and that it is going to be permanent in nature.

 
Event Description

On (b)(4) 2013, it was reported that for a while the vns was efficacious for the patient but when the settings were increased, the patient began experiencing abdominal cramping which became so bad the patient wanted the device disabled. After several years, the patient had transferred care and the new physician decided to start the patient back up with vns the past summer to try vns again. He had gradually ramped the patient up, but the patient¿s abdominal issues came back, as well as voice alteration with stimulation. The physician stated that now that they have tried their best with vns for this patient, he is going to turn the patient¿s device off as the side effects are too much for the patient to handle. It was indicated the device is functioning properly. The physician believes that the abdominal issues occur with stimulation and that for the most part, the event had subsided when the patient¿s device had previously been disabled. The patient had not experienced this event pre-vns. The only interventions being planned at this time is device disablement. Previously in 2007 it was reported that the patient experienced constant abdominal cramping, and that this resolved when the output current was decreased to 0. 25ma. The physician reported that the patient has had this symptom "to varying degrees in the past", but the patient "feels the abdominal cramps have been worse since vns. ".

 
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 Key3137212
Report Number1644487-2013-01630
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number102
Device LOT Number013840
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/30/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/03/2005
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: 05/30/2013 Patient Sequence Number: 1
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