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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/01/2009
Event Type  Injury  
Event Description

It was reported that the vns patient was referred to a surgeon to have the vns device removed due to the patient experiencing painful stimulation in the neck. The physician believed that there was a problem with the device, which was causing the painful stimulation, however, the physician did not perform diagnostic testing on the patients device following the onset of the painful stimulation. The patient subsequently had surgery, where the lead and generator were explanted. Prior to explanting the device, the surgeon performed a system diagnostic test, which revealed normal device function. Therefore, with normal diagnostic test results performed following the onset of the painful stimulation, the physician's suspicion of a device deficiency has been confirmed invalid. The explanted lead and generator have been returned to manufacturer where analysis is underway.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1514057
Report Number1644487-2009-02356
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/23/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2008
Device MODEL Number102
Device LOT Number015579
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/16/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/23/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2006
Is The Device Single Use? Yes
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/21/2009 Patient Sequence Number: 1
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