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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 03/25/2013
Event Type  Injury  
Event Description

Additional information received on (b)(4) 2013 when it was reported that the patient was doing much better and the incision site is healing well.

 
Event Description

On (b)(6) 2013, it was reported that the vns patient was complaining of pain in both incision sites that had started on (b)(6) 2013, but is working with her pain management doctor to get relief. The patient's vns had not yet been turned on. On (b)(6) 2013, the patient reported that on (b)(6) 2013, she noticed a small amount of "green cloudy" drainage from the "top" portion of her generator incision, left axilla. On (b)(6) 2013. The very top of the same incision "opened up", approximately 2mm, and there was no further drainage. The patient went to the emergency room and didn't tell them about the prior day's drainage and they just cleaned the incision and placed a gauze dressing over the incision. The patient stated that in the last week she has run a fever up to 101 twice, has taken ibuprofen and has had no fever for the last few days. The patient stated that the left axillary incision is red, swollen, and tender to the touch; pain scale of 7-8. The patient stated that she showered about the 4th day post-operation. The physician reported that the patient needs to go to the emergency room immediately because the vns could be infected and therefore, might have to be removed or revised. The physician later reported that the event was due to the patient's surgery and the only intervention planned was pain medications. The patient's generator was turned on. The surgeon is working with a local physician where the patient lives to follow-up on the patient's infection. Good faith attempts for the patient's implanted product information were made to the implanting hospital but the information has not been received to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3074526
Report Number1644487-2013-01139
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2013
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
Event Location Other
Date Manufacturer Received04/25/2013
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: 04/24/2013 Patient Sequence Number: 1
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