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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 07/29/2014
Event Type  Malfunction  
Event Description

The ent surgeon reported that during implant surgery the surgeon noticed that the negative and positive electrodes were stuck together. It was reported that it appeared as though the electrodeshad melted together. The surgeon was able to pull the electrodes apart and reported that there did not seem to be any visible damage to the lead. Device diagnostics once implanted were within normal limits. This event was previously investigated and concluded to likely be due to a manufacturing operator error and was missed during inspection. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

 
Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr incorrectly stated that the event was previously investigated and concluded to likely be due to a manufacturing operator error and was missed during inspection. The cause for the event remains unknown, and the device is still implanted in the patient.

 
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Brand NameLEAD MODEL 304
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 Key4038355
Report Number1644487-2014-02107
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2018
Device MODEL Number304-20
Device LOT Number202968
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/13/2014
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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