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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 03/31/2011
Event Type  Injury  
Event Description

On (b)(6) 2011, it was reported by a vns implanting surgeon to the case manager that the vns patient was seen on (b)(6) 2011, complaining of a "burning sensation" in her neck. The patient's generator had been recently replaced and the generator was placed in her axilla region instead of the clavicular region. The patient is having discomfort with the generator in her axilla region, especially when she sleeps at night, therefore, she was referred to the surgeon for repositioning of her generator. No diagnostics were performed. On (b)(6) 2011, the surgeon moved the patient's generator to just under the clavicle. However, the surgeon used electrocautery to open up the patient. The manufacturer's consultant was advised that there is a safety alert regarding the use of electrocautery with vns because it could possibly disable the generator or affect the battery life. The consultant was informed that he needed to review the safety alert with the surgeon. It was reported that they were able to communicate with the generator and everything was fine after the surgery. Good faith attempts for further information from the patient's physician have been to no avail thus far. If additional information is received, it will be reported.

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Manufacturer (Section D)
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
MDR Report Key2070197
Report Number1644487-2011-00887
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/01/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2012
Device MODEL Number102R
Device LOT Number2703
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/01/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 04/25/2011 Patient Sequence Number: 1