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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 01/01/1998
Event Type  Injury  
Event Description

It was reported in a review of a journal article titled vagus nerve stimulator implantation in children, that one patient experienced traumatic dehiscence of the chest wound secondary to wrestling 9 days after implantation. A small hematoma near the generator was drained at the bedside through the small wound dehiscence. There was no sign of infection. Antibiotics were administered for 48 hours. The patient was discharged while maintaining oral antibiotic therapy until the wound closed secondarily. No signs of infection had become present 8 months following the injury.

 
Manufacturer Narrative

Article citation: kirse, d. , werle, a. , murphy, j. , eyen, t. , bruegger, d. , hornig, g. , torkelson, r. "vagus nerve stimulator implantation in children. " archives of otolaryngology - head and neck surgery vol. 128 (nov 2002). 1263-1268.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1541695
Report Number1644487-2009-02587
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 10/19/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/19/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/18/2009 Patient Sequence Number: 1
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