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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 02/26/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7). The device was programmed off after observing the high impedance reading. It was reported that x-rays were performed and that the patient would be referred for surgery. X-rays reviewed by manufacturer identified a fracture within the lead in the neck portion. Surgical intervention has not been performed to date.

 
Event Description

It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. It was reported that during the surgery, an issue was found with the lead. The explanted devices have not been received by the manufacturer to date.

 
Event Description

Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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.

 
Event Description

The explanted devices were returned to the manufacturer for analysis. Analysis of the lead has not been completed to date. Analysis was completed on the generator. There were no anomalies found with the pulse generator. The generator performed according to functional specifications.

 
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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 Key3702853
Report Number1644487-2014-00781
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number302-20
Device LOT Number011537
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/24/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2004
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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