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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105

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CYBERONICS, INC. PULSE GEN MODEL 105 Back to Search Results
Model Number 105
Event Date 04/15/2011
Event Type  Injury  
Event Description

It was initially reported on (b)(6) 2011 that the pt had been admitted to the hospital due to an infection and was scheduled to have her generator explanted. The pt had been picking at her incision site. She was previously provided oral antibiotics, but the infection did not improve. Additional information was rec'd from the surgeon indicating that the infection was first observed right after implant. Cultures of the infection indicated that the infection was methicillin-resistant staphylococcus aureus. The infection site was described as "grossly purulent". The generator was explanted, but no other interventions were taken or planned. The surgeon again indicated that the pt had scratched open her incision site, causing the infection. The infection has since resolved. Manufacturer records indicated that both generator and lead were sterilized by hydrogen peroxide prior to distribution.

 
Manufacturer Narrative

Method: device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NamePULSE GEN MODEL 105
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2133615
Report Number1644487-2011-01355
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/20/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2012
Device MODEL Number105
Device LOT Number2877
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/20/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2010
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: 06/16/2011 Patient Sequence Number: 1
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