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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 01/01/2007
Event Type  Injury  
Event Description

It was reported that a vns patient developed multiple dehiscence chest wounds as a result of patient device manipulation. The patient's generator was eventually moved to the midline of the patient's chest and later the device began to extrude from the patient's skin as a result of continued manipulation and weight lifting. The patient's implanting surgeon explained that weight lifting was a suspected contributing factor as the patient allowed the bench press bar to hit his chest between reps. These events led to the eventual explantation of the patient's generator, though the patient's lead was allowed to remain implanted. The explanted generator was returned to the manufacturer and an analysis of the device confirmed proper device function. Additional information was received from the patient's implanting surgeon, who indicated that the patient's lead had begun to extrude through a small hole in the skin of the patient's chest and added that the contaminated ends had fostered the development of an abscess/infection with colitis in this area. The surgeon indicated that the event was once again likely related to patient manipulation and that a majority of the lead was surgically removed through the small hole in the patient's chest, adding that the remainder of the device would be removed if additional issues developed. The surgeon also stated that the patient's abscess was drained and treated with antibiotics and "is currently healing quite well" manufacturer's report # 1644487-2009-01810 will reference the product information of the patient's lead.

 
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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 Key1455916
Report Number1644487-2009-01809
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/29/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2005
Device MODEL Number102
Device LOT Number009157
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/31/2007
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/29/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2003
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: 08/26/2009 Patient Sequence Number: 1
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