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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/23/2009
Event Type  Injury  
Event Description

Reporter indicated that a pt developed an infection at the electrode incision site after the wound at the incision site partially opened. The wound opened because the sutures used in the implant procedure were not secured properly, and became loose. The medical professional was unsure whether or not any pt manipulation had occurred, which may have possibly contributed to the wound opening. The physician opened the wound completely, cleaned it, and allowed it to heal. The wound was re-closed once the infection cleared and the pt is doing well. There are no plans to remove the pt's device. No cultures were taken to identify the infection type. Dhr for the pt's lead and generator were reviewed, and sterility prior to shipment was confirmed.

 
Manufacturer Narrative

Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1327917
Report Number1644487-2009-00395
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 02/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number302-20
Device LOT Number2192
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/18/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2008
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: 02/27/2009 Patient Sequence Number: 1
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