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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Generator; Device Operates Differently Than Expected
Event Date 08/25/2014
Event Type  Injury  
Event Description

It was reported by the patient that the vocal cord paralysis was permanent. The explanted generator was requested for evaluation; however, it was discarded and cannot be returned.

 
Event Description

It was reported that the vns patient underwent surgery on (b)(6) 2015 to explant the generator due to vocal cord paralysis and tachycardia which the physician attributed to vns. The lead was not explanted during the procedure. The patient began experiencing these issues following initial implant surgery on (b)(6) 2014. No further information relevant to the event has been received to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: it was inadvertently reported on the initial report that the physician attributed the tachycardia to vns. Brand name, corrected data: the suspect device was inadvertently reported as the generator and was the brand name was reported incorrectly on the initial report. Type of device, corrected data:the suspect device was inadvertently reported as the generator and the type of device was inadvertently reported incorrectly on the initial report. Model, serial number, lot number, expiration date, corrected data: the suspect device was inadvertently reported as the generator and the model, serial number, lot number and expiration dates were inadvertently reported incorrectly on the initial report. Explanted date, corrected data: the suspect device was inadvertently reported as the generator and an explant date was incorrectly reported on the initial report. No known surgery to explant the suspect lead device has occurred to-date. Evaluated by mfr, corrected data: it was inadvertently reported on follow-up #1 that the device was not returned to the manufacturer when it had already been correctly reported on the initial mdr, resulting in a duplicate statement. Device manufacture date, corrected data: the suspect device was inadvertently reported as the generator and the device manufacture date was incorrectly reported on the initial report. Evaluation codes, corrected data: the conclusion code was inadvertently reported incorrectly on the initial report.

 
Event Description

It was reported by the patient that she has experienced nerve damage in her face, and paralysis on the left side of her face as a result of vns surgery. The patient reported swelling on her neck with the nerve damage to her face. The patient's physician and cardiologist have reported they believe the tachycardia to be pre-existent and not related to vns. Attempts for additional information have been unsuccessful to-date.

 
Event Description

The patient has stated that the generator was removed because her left vocal cord was clipped during the surgery and has caused voice issues. The patient reported pain in her neck and stated she had no feeling on the left side of the face as a result of the surgery, which has not fully resolved to-date. Attempts for additional information have been unsuccessful to-date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key4762712
Report Number1644487-2015-04663
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 04/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2018
Device MODEL Number304-20
Device LOT Number202906
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/31/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2014
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: 05/11/2015 Patient Sequence Number: 1
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