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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 07/02/2014
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes were received which indicated that a patient was having difficulty breathing. The patient had been evaluated by a pulmonologist and an ear, nose, and throat (ent) physician who were unable to determine the cause of the breathing difficulties. The ent observed paradoxical vocal cord movement. Vns function was noted to be normal with normal diagnostics. Device settings were adjusted to try to alleviate the breathing problems but were unsuccessful. The patient's breathing problems were alleviated by disabling vns therapy. It is noted that the patient's generator and lead are both implanted on the right side following a high impedance observation on a prior lead implanted on the left side (reported in mfg. Report #: 1644487-2014-00786). The providers are considering moving the system back to the left side but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The provider reported that the patient's breathing difficulties started in (b)(6) 2014, at approximately the 3rd clinic visit after implant. The provider stated he did not know the cause of the paradoxical vocal cord movement.

 
Event Description

Information was received indicating that since the time of vns disablement the patient¿s breathing has improved and the patient has had 2 seizures. The patient underwent full system revision which moved the vns system back over to the patient¿s left side. The reason for explant was stated to be coughing which caused pain for the patient. The lead on the right side was not explanted.

 
Manufacturer Narrative

Supplemental report #2 should have stated that the reason for system revision, and not suspect device explant, was due to coughing which caused pain for the patient. Supplemental report #2 inadvertently indicated an explant date of (b)(6) 2015, however, the suspect device was not explanted.

 
Event Description

The reason for system revision was stated to be coughing which caused pain for the patient.

 
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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 Key5071956
Report Number1644487-2015-05651
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup
Report Date 08/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2016
Device MODEL Number304-20
Device LOT Number3497
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2014
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: 09/11/2015 Patient Sequence Number: 1
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