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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 Problem Insufficient Information
Event Date 12/03/2014
Event Type  Injury  
Event Description

It was reported on that the vns patient had left vocal cord paralysis following implant surgery on (b)(6) 2014 which required the patient to go to the emergency room. The patient did not have a prior history of vocal cord paralysis. Follow up with the patient's treating physician indicated that the believed cause for the left vocal cord paralysis was surgical trauma. The patient was referred to an ent.

 
Event Description

Additional information was received that the patient was referred for vns device explant due to chronic pain since implant, which was not resolved even though the device was disabled. The patient underwent a generator and lead explant surgery on (b)(6) 2015. The explanted devices were received by the manufacturer for analysis. However, analysis has not been completed to date. Additional information was received that the patient's diagnostic results have been within normal limits. Furthermore, the explant surgery was taken for patient comfort, not to preclude a serious injury.

 
Event Description

Analysis of the explanted generator and lead was completed. Analysis of the generator showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the return lead was completed as well. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Furthermore, additional information was received that the patient's vocal cord paralysis has resolved since first being reported.

 
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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 Key4392406
Report Number1644487-2015-03543
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/09/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/09/2018
Device MODEL Number304-20
Device LOT Number200340
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/27/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2014
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: 01/07/2015 Patient Sequence Number: 1
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