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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 08/16/2013
Event Type  Malfunction  
Event Description

It was reported that the patient was seen on (b)(6) 2013 and high lead impedance was observed. The physician programmed the patient's device off to 0ma output current. The patient was referred to the surgeon for evaluation and x-rays were ordered, but will likely not be sent to the manufacturer. The physician does not believe that trauma or manipulation contributed to the event. Revision surgery was completed on (b)(6) 2013. Review of the lead device history records confirmed all quality tests were passed prior to distribution. It was noted that the patient previously experienced high impedance after implant in (b)(6) 2010 due to the electrode not being adequately seated on the nerve (reported in mfr #: 1644487-2010-02723). The explanted generator and lead were returned on (b)(6) 2013 and are pending product analysis.

 
Manufacturer Narrative

Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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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 Key3363567
Report Number1644487-2013-02864
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/26/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number302-20
Device LOT Number2643
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/26/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/15/2010
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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