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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/16/2011
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported by the nurse that the vns patient has learning disabilities and behavioral difficulties and that keeping the neck wound clean was very difficult.

 
Event Description

On (b)(6) 2013 the nurse reported that she cannot provide any further information.

 
Event Description

On (b)(6) 2012 it was reported that the patient had their generator and lead explanted due to an infection and that they were going to be re-implanted. The timeline of events were provided to be the following; on (b)(6) 2011 the wound site was tender to the touch and on (b)(6) 2011 the neurosurgeon assessed the event and thought it to be a superficial infection. On (b)(6) 2012 the wound was washed out and re-sutured. On (b)(6) 2012 the vns was explanted due to the unresolved infection. On (b)(6) 2012 they attempted to implant the device again but when the surgeon opened him up, he felt that the scarring and risk of infection was too great. Therefore it wasn¿t until (b)(6) 2013 that a new vns system was able to be implanted, but on the right side. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 103
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 Key3147650
Report Number1644487-2013-01687
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number103
Device LOT Number3045
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/30/2011
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: 06/05/2013 Patient Sequence Number: 1
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