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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 06/29/2014
Event Type  Injury  
Event Description

It was reported that the patient was referred for generator and lead replacement due to shooting pain up to the patient's ear with device stimulation. It was reported that the generator would be replaced prophylactically due to the amount of time implanted. An implant card was received indicating that the patient underwent generator and lead replacement due to prophylactic reasons. The explanting facility discarded the explanted devices; therefore, product analysis cannot be performed. The physician reported that the patient was hit in the neck with something and the pain with device stimulation began. It was reported that device diagnostics were within normal limits prior to explant. The physician believed it would be best to have the entire vns system replaced due to the pain and time the generator had been implanted.

 
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Brand NameLEAD MODEL 302
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 Key4120189
Report Number1644487-2014-02487
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number302-20
Device LOT Number200560
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/29/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2007
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: 09/25/2014 Patient Sequence Number: 1
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