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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
Device Problems Fluid Leak; Appropriate Term/Code Not Available
Event Date 12/12/2017
Event Type  Malfunction  
Event Description

During a generator replacement surgery, the surgeon observed a break in the lead insulation and replaced the lead as well. The impedance was within normal limits prior to lead revision (2203ohms). It was reported that there was a kink / twist in the lead. The explanted lead has not been received to date.

 
Event Description

The generator and lead were returned. Abraded openings were noted on the outer silicone tubing. Abrasions were noted on the inner and outer silicone tubing at multiple locations. The outer silicone tubing has a compressed appearance at multiple locations. The lead assembly has dried remnants of what appear to have once been body fluids/betadine solution inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut end of the returned lead portion. Since a portion of the lead (including the 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 other anomalies were identified in the returned lead portion. Pa on the generator: the pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key7167451
Report Number1644487-2018-00020
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/16/2004
Device MODEL Number302-20
Device LOT Number6575
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2002
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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