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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 103 GENERATOR

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CYBERONICS PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/15/2014
Event Type  Injury  
Event Description

It was reported that the vns patient presented an infection that required surgical full vns system replacement. It was reported that the new vns system was implanted on the right side. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Further information was received indicating that the generator and the lead were explanted in two separate interventions. The health care professional waited 3 months for the infection to resolve and a new vns system was implanted on the right side. The explanted devices have not been returned to the manufacturer to date.

 
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
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4921001
Report Number1644487-2015-05216
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL Number103
Device LOT Number202972
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/29/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/17/2014
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: 07/17/2015 Patient Sequence Number: 1
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