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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 03/07/2014
Event Type  Injury  
Event Description

It was reported that the patient underwent generator and lead explant due to painful stimulation. The generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. No additional relevant information havs been received to date.

 
Event Description

Further follow-up revealed that the patient was not reimplanted. It was reported that the patient reported neck tightness and pulling at the nerve attachment site of the lead.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis, which did not revealed any anomalies.

 
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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 Key4128688
Report Number1644487-2014-02513
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number304-20
Device LOT Number3038
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/27/2011
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: 09/30/2014 Patient Sequence Number: 1
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