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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 08/15/2013
Event Type  Injury  
Event Description

It was initially reported that after the patient was implanted she began having a reaction and the physician felt the patient was rejecting the device. The patient had an infection and the skin was flaking around the generator. The patient has multiple allergies. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution and sterility was confirmed. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution and sterility was confirmed.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
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 Key3360624
Report Number1644487-2013-02832
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial
Report Date 08/22/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number103
Device LOT Number202415
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/22/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/26/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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