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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 07/26/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported on 07/26/2016 from the patient that she had a replacement surgery on (b)(6) 2016. She stated that today she turned her head to the left and got a shocking sensation in her neck. The shocking is not constant and has only happened once. She also reported that she has had some blackouts that have caused her to fall down. She reported that she did fall on the device. These issues first began in (b)(6). It was reported that the physician turned the autostimulation settings from 2. 25 ma to 2. 0 ma and normal mode current is also at 2. 0 ma. She is seeing a surgeon for lead revision consult. All impedance levels are normal approximately 2900 ohms. No surgical intervention has occurred to date.

 
Event Description

Information was received on 08/22/2016 that indicated that the physician believes that the patient's blackouts are unrelated to vns therapy and likely psych related. Patient is insistent and self referred herself to a surgeon to assess lead revision but she was not referred. The patient met with the surgeon who determined there are no issues with the vns device.

 
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Brand NamePULSE GEN MODEL 106
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 Key5889900
Report Number1644487-2016-01874
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 07/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/04/2018
Device MODEL Number106
Device LOT Number4696
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2016
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: 08/19/2016 Patient Sequence Number: 1
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