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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Device Operates Differently Than Expected
Event Date 06/20/2014
Event Type  Injury  
Event Description

It was reported that the vns patient felt her generator moving and flipping in her chest which was causing burning sensations. The patient¿s device was tested and showed normal device function. The patient previously reported that her magnet was not aborting her seizures and that magnet mode stimulation was causing burning sensations in the chest. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

It was reported that the patient underwent surgery to remove the generator from the chest pocket, and place it in the left shoulder. The patient experienced more discomfort following the repositioning of the generator. Additional surgery is likely, but has not occurred to date.

 
Event Description

The patient's generator was explanted and replaced on (b)(6) 2015. The patient's device was discarded after explant and will therefore not be received for analysis.

 
Event Description

It was found from the surgeon's office who had originally implanted the generator in 2012 that the generator was secured with a non-absorbable silk suture during implantation.

 
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Brand NamePULSE GEN MODEL 102
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 Key4535345
Report Number1644487-2015-03937
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 01/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number102
Device LOT Number3377
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/18/2012
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: 02/23/2015 Patient Sequence Number: 1
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