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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 01/14/2010
Event Type  Injury  
Event Description

Reporter indicated a patient developed wound dehiscence at the vns generator site in the chest and at the vns lead electrode site in the neck two days after initial implant surgery. An actual infection was not reported. The patient was hospitalized and received intravenous antibiotics and wound packing, followed by exploratory surgery of the chest and neck wounds, with reclosure of the surgical wounds. The reporter stated the patient was sensitive to the absorbable sutures used in the initial surgery, which caused the wound dehiscence. The wounds were reclosed with nylon sutures. At the patient's follow-up visit, the wounds were healing well with no signs of infection and the nylon wound closure sutures were removed.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1599288
Report Number1644487-2010-00248
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/18/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2011
Device MODEL Number103
Device LOT Number2495
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/18/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2009
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: 02/05/2010 Patient Sequence Number: 1
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