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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 05/22/2013
Event Type  Malfunction  
Event Description

It was reported that during replacement surgery on (b)(6) 2013, the patient¿s device was tested and diagnostic results showed high impedance. The lead pin was reinserted into the generator header multiple times, but the device continued to show high impedance. The patient¿s generator was explanted and generator diagnostic showed end of service. No issues were noted with the lead electrodes attachment to the vagus nerve. The surgeon elected to replace the patient¿s generator and lead. Following replacement, diagnostic results continued to show high impedance. The vagus nerve was irrigated and the impedance value was reported to be decreasing; however, the patient device continued to show high impedance. The lead pin was reinserted into the generator header and diagnostic results finally showed lead impedance within normal limits. The surgeon attributed the high impedance to fibrosis. X-rays prior to surgery were reported by the surgeon to be unremarkable. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Age at time of event or date of birth; corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Sex; corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Brand name, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Implant date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Explant date, corrected data: previously submitted mdr inadvertently provided an incorrect explant date. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.

 
Event Description

Patient and product information was obtained.

 
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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 Key4012761
Report Number1644487-2014-02035
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2015
Device MODEL Number304-20
Device LOT Number3083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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