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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 12/12/2014
Event Type  Malfunction  
Event Description

It was reported that high lead impedance was observed on system diagnostics on (b)(6) 2014. The device was not disabled. Although surgical intervention is likely to resolve the high impedance, it has not occurred to date.

 
Event Description

It was later reported that the patient had generator and lead replacement on (b)(6) 2015. The generator was replaced prophylactically, and the lead was replaced due to lead discontinuity. The explanted devices were received by the manufacturer for analysis. However, analysis has not been completed to date.

 
Event Description

Analysis was completed on the lead and generator. Scanning electron microscopy images of the positive coil end show that pitting or electro-etching conditions have occurred at the end of the coil. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since the a portion of the lead (including portion of electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

 
Manufacturer Narrative

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

 
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.

 
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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 Key4382825
Report Number1644487-2015-03524
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 12/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2009
Device MODEL Number302-20
Device LOT Number1548
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/26/2006
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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