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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 Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported on (b)(6) 2016 that this patient has high impedance. No other additional information has been obtained to date.

 
Event Description

The patient had vns explant surgery, and both the generator and lead were explanted. System diagnostics were not performed prior to surgery, so the previously reported high impedance was not confirmed. Also, the explant was reported to have been due to the patient not have efficacy. Programming history did not have diagnostic results available, except from the date of implant, which were within normal limits. The explanted products have not been received to date.

 
Event Description

The explanted products were discarded. Therefore, no analysis could be performed.

 
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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 Key6087789
Report Number1644487-2016-02595
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 04/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/12/2009
Device MODEL Number302-20
Device LOT Number200364
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/13/2006
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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