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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 10/01/2014
Event Type  Injury  
Event Description

It was reported that the patient was experiencing pain at the generator site and wants to have a complete system replacement. It was reported that the pain was occurring with device stimulation. The patient was scheduled for vns system replacement. No surgical intervention has been performed to date.

 
Event Description

The explanting facility does not return explanted products unless they are notified beforehand. The explanted devices are therefore not available for return for analysis.

 
Event Description

It was reported that the patient underwent a full replacement on (b)(6) 2014 due to the patient's discomfort. Attempts have been made for product return but the explanted devices have not been received to date.

 
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Brand NamePULSE GEN MODEL 102R
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4274291
Report Number1644487-2014-03105
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/28/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2009
Device MODEL Number102R
Device LOT Number016869
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/11/2007
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: 11/24/2014 Patient Sequence Number: 1
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