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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/17/2007
Event Type  Injury  
Event Description

It was reported via clinic notes that vns pt developed infection at the generator site. Three weeks after vns generator re-implantation, the pt developed redness purulence from the chest incision. Despite iv antibiotics, this wound worsened with increasing fluid collection underneath the wound. The generator pocket became swollen and the neurosurgeon drained the excess fluids. At this point, the surgeon decided to remove pt's vagal nerve stimulator and drain the postoperative wound infection. The pre-existing incision which had largely dehisced. The physician used pulse irrigator and irrigated extensively; however, the infection recurred so he used a suction drain. Dhr review of the generator showed that both generator and the lead were sterilized with hp on (b)(6) 2006. The pt was later reimplanted on (b)(6) 2010 with a new vns generator and lead. Good faith attempts to obtain additional info from the implanting surgeon have been unsuccessful to date.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1956374
Report Number1644487-2011-00008
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2008
Device MODEL Number102
Device LOT Number015030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/10/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
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: 01/07/2011 Patient Sequence Number: 1
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