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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 06/18/2011
Event Type  Injury  
Event Description

On (b)(6), 2011, the vns implanting surgeon reported that the vns pt had his vns explanted on (b)(6), 2011 due to an (b)(6) infection. They were unaware of any plans to replace it. The surgeon's nurse reported that the vns pt went to the er on (b)(6), 2011 for swelling and pain of the incision sites on the neck and chest. The pt was then placed on oral antibiotics. On (b)(6), 2011, the pt saw their surgeon and the infection has not gotten any better since their er visit two days prior. The surgeon prescribed stronger antibiotics and explained to the pt that if they don't feel better in 12-24 hrs, to visit the surgeon again. The pt was hospitalized on (b)(6), 2011 for the infection and placed on iv antibiotics of vancomycin and aosyn. Cultures of both sites were taken at that time and the infection was discovered to be (b)(6). The pt was explanted on (b)(6), 2011 because of the infection. The surgeon's nurse reported that it is unclear at this time if the infection is related to the vns device or a problem with the surgery. The pt is very alert and did not touch or scratch the site and no trauma was noted that could have caused/contributed to the infection. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution. If further info is received, it will be reported.

Manufacturer Narrative

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

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Manufacturer (Section D)
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
MDR Report Key2180925
Report Number1644487-2011-01658
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2012
Device MODEL Number102
Device LOT Number2749
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/27/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 07/22/2011 Patient Sequence Number: 1