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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 10/14/2014
Event Type  Malfunction  
Event Description

Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. No other obvious anomalies were noted. Note that since a portion of the lead assembly, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, including the (+) white electrode was not returned for analysis, an evaluation cannot be made on that portion of the lead.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the vns patient¿s device showed high impedance. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted devices have not been returned to date.

 
Manufacturer Narrative

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

 
Event Description

The explanted devices have been returned to the manufacturer where analysis is currently underway.

 
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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 Key4347975
Report Number1644487-2014-03425
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 11/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2009
Device MODEL Number302-20
Device LOT Number1766
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2006
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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