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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 02/24/2015
Event Type  Malfunction  
Event Description

Analysis of the generator was completed. The pulse generator performed according to functional specifications. The battery showed an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 43. 645% of the battery had been consumed. No performance or any other type of adverse conditions was found with the pulse generator.

 
Event Description

The explanted devices were received by the manufacturer on 04/20/2015. Analysis is underway, but it has not been completed to date. Analysis of the lead was completed. Scanning electron microscopy images of the connector pin show that the pitting or electro-etching conditions have occurred on the pin surface at the setscrew marks¿ location. No obvious adverse effect was identified on the device performance as a result of this condition. A portion of the lead including the electrode array was not returned for analysis, rendering an evaluation and resulting commentary on that portion of the lead impossible. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
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

An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity. The lead impedance with the new system was within normal limits (1793 ohms). The explanted devices are expected to be returned for analysis, but have not been received to date. No additional relevant information has been received to date.

 
Manufacturer Narrative

Device failure occurred, 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 Key4641405
Report Number1644487-2015-04291
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2006
Device MODEL Number302-20
Device LOT Number10789
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/20/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/30/2004
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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