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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 302-30
Event Date 08/28/2008
Event Type  Injury  
Event Description

On (b)(6) 2013 clinic notes were received from (b)(6) 2008 which indicates that the patient recently underwent vns surgery and returned to the physician's office with some separation of her left neck and chest incisions, due to her picking at the incision sites and dressings. Additionally, the patient had significant contact dermatitis from her dressings. With betadine and valium this has all resolved. It was stated that the left neck incision is healing nicely although it does have mild superficial separation as well as her left chest incision. There is no surrounding erythema or drainage. Clinic notes dated (b)(6) 208 indicate that the patient underwent vns surgery 4 days ago and through the weekend developed an erythematous pruritic rash on her left chest an neck. The patient had completely removed her dressings and picked at her left neck incision causing superficial separation, apparently she continues to pick at her left neck. On exam, she had superficial separation of the neck incision, although fairly superficial. The physician stated that the erythematous rash over the left neck and thigh is consistent with tape irritation. The left chest incision had surrounding erythema as well, although it is covered with tegaderm dressing. The patient was given valium to provide some sedation and benadryl for her contact dermatitis. It was stated that the patient needs constant monitoring to prevent her from altering her incision further. Clinic notes dated (b)(6) 2008 indicated that he patient was seen one week ago and had significant dermatitis of her left chest and neck which is likely due to the dressing which was applied postoperatively. The patient was noted to have been picking at her dressings and removing them and then picking at her incision sites. On examination, the left neck incision is healing, although not completely closed. The physician noted that he undressed the left chest incision and revealed a small superficial separation. There were no obvious signs of infection. Clinic notes dated (b)(6) 2008 stated that the patient's wound is completely healed and she has no further rash. The surgeon and treating nurse practitioner were noted to have been retired for more than two years so no additional information would be available.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3062982
Report Number1644487-2013-01044
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/21/2009
Device MODEL Number302-30
Device LOT Number1541
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/28/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2006
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: 04/17/2013 Patient Sequence Number: 1
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