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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 06/27/2014
Event Type  Malfunction  
Event Description

Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
Event Description

During prophylactic generator replacement it was reported that prior to the surgery low impedance (668 ohms) was observed. The generator pocket was opened and low impedance (322 ohms) was again observed. It was reported that fluid was observed inside the lead wire. It was reported that lead replacement would be performed at a later date. The generator was received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date. No known surgical interventions have been performed to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted lead was returned to the manufacturer for analysis which confirmed openings in both the inner tubing sections in adjacent areas that exposed the conductive quadfilar coils, creating an intermittent short-circuit condition. The abraded openings and slice mark found on the outer silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. The generator replacement surgery on (b)(6) 2015 was reported in manufacturer report #1644487-2015-04111.

 
Manufacturer Narrative

Date of this report, corrected data: the initial manufacturer report inadvertently provided an incorrect aware date. The aware date for the initial report is 07/11/2014. Date received by manufacturer, corrected data: the initial manufacturer report inadvertently provided an incorrect aware date. The aware date for the initial report is 07/11/2014.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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 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 Key3994857
Report Number1644487-2014-01974
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number302-20
Device LOT Number200788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/19/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/28/2008
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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