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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 Type  Injury  
Event Description

It was reported that a vns pt developed an infection in the chest generator site area and was referred for generator removal surgery as well as removal of part of the lead near the generator. At the moment it is unk when the infection started and what could have contributed to the infection as good faith attempts to obtain additional information have been unsuccessful to date. Furthermore, the surgeon's office indicated the pt's generator was visible through the incision site and it was unk if pt manipulation or trauma contributed to the event. The pt underwent explant surgery as scheduled and at the moment the name of the explanting site is unk.

 
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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 Key1801202
Report Number1644487-2010-01838
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number102
Device LOT Number200989
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/12/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2008
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: 08/11/2010 Patient Sequence Number: 1
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