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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
Event Date 05/31/2012
Event Type  Malfunction  
Event Description

It was reported that the patient feels pain at the generator site up to the neck area. It was reported that it is unclear whether or not the pain occurs with device stimulation. There has been no falls or trauma that may have caused the pain. Device diagnostics were within normal limits (3337 ohms). Clinic notes dated (b)(6) 2012 note that the patient has some vague complaints of neck pain over his left side, moving down to his left arm and leg. It was noted that the patient describes the pain at sharp in nature and that the patient attributes the pain to vns. Clinic notes dated (b)(6) 2015 note that the patient is having significant discomfort on his left side with vns stimulation. It was noted that the physician believes the generator and lead need to be replaced. The patient underwent generator and lead replacement. The implant card indicated that the generator and lead were replaced due to lead discontinuity and adverse event. No additional relevant information has been received to date.

 
Event Description

The explanted lead and generator were returned for evaluation. Analysis is underway but has not been completed to date.

 
Event Description

Analysis of the explanted generator was completed on 06/02/2015. A comprehensive automated electrical evaluation 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 explanted lead was completed on 06/04/2015. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4723453
Report Number1644487-2015-04537
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL Number304-20
Device LOT Number2900
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/03/2011
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: 04/23/2015 Patient Sequence Number: 1
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