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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 12/11/2014
Event Type  Malfunction  
Event Description

The patient underwent surgery. During surgery, it was observed that the lead appeared to be corroded. It was reported that the lead appeared to be discolored and device diagnostics resulted in high impedance. Both the generator and lead were replaced. An implant card was received indicating that the generator was replaced due to battery depletion and the lead was replaced due to lead discontinuity. The explanted devices have not been received for analysis to date.

 
Manufacturer Narrative

Corrected data: new information received corrects the suspect device. Corrected data: a device malfunction is suspected to have caused the serious injury. Device failure is suspected, but did not cause or contribute to a death.

 
Event Description

Clinic notes were received indicating that the vns patient had five seizures in one day. The patient¿s medications were subsequently adjusted. The patient¿s device was noted to be running out of battery life so the patient was referred for surgery. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
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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 Key4409566
Report Number1644487-2015-03594
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number304-20
Device LOT Number201702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/26/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/07/2011
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: 01/12/2015 Patient Sequence Number: 1
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