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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 04/12/2016
Event Type  Injury  
Event Description

It was reported on (b)(6) 2016 that the physician saw the patient that day and she was complaining of painful erratic stimulation in her left neck when she turns her head to the left. This started about 1 week prior and there was no trauma or event that seemed to have started it. The physician checked diagnostics with her facing forward and also turning her head to the left. Notes state to follow-up to replace vns / lead if malfunction continues but this likely refers to the painful stimulation as diagnostics showed the vns was functioning well and physician lowered settings to help tolerability. No malfunction of the device was observed. The patient is now scheduled for an explant of the device. Surgery has not occurred to date.

 
Event Description

It was reported on (b)(6) 2016 that the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was discarded after explant.

 
Manufacturer Narrative

Corrected data, supplemental mdr #1 inadvertently reported that the patient had a replacement while the surgery was only an explant surgery.

 
Event Description

The patient generator was explanted (b)(6) 2016. Clinic notes were received on 10/21/2016 for the patient to be re-implant with a m106. The notes state that the previous vns stimulator was removed (model 103) because painful stimulation was triggered by turning head towards it and she has to turn her entire body not just head to avoid trigger of vns stimulation. The electrodes are still in place but the surgeon suspects the electrodes may be fractured but he will check the old lead with the new vns during surgery to see if it¿s still working, otherwise he will implant new electrode. No additional information has been received to date.

 
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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 Key5653184
Report Number1644487-2016-01009
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/28/2016
Device MODEL Number103
Device LOT Number202945
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2014
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: 05/13/2016 Patient Sequence Number: 1
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