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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problems Generator; Device Operates Differently Than Expected
Event Date 11/05/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient felt shocking sensations in the neck. The patient's settings were decreased, which temporarily resolved the issue. However, the patient later reported that she felt like she was being stabbed in the neck. The patient was referred for possible generator replacement surgery due to the painful stimulation. The physician most likely believes that the potential cause of the painful stimulation is the generator, since they referred the patient for generator replacement surgery. No surgical intervention has occurred to date.

 
Manufacturer Narrative

 
Event Description

The patient's neurologist referred the patient for surgery due to the painful stimulation, but it was only for patient comfort. However, when the patient had a consult with the surgeon, only the patient's settings were adjusted. The surgeon ran system diagnostics, which were within normal limits, and adjusted the patient's settings in response to the painful stimulation. No surgical intervention has occurred to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key5256324
Report Number1644487-2015-06611
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/05/2015
Device MODEL Number105
Device LOT Number3744
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/10/2013
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: 11/30/2015 Patient Sequence Number: 1
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