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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
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

On (b)(6) 2015 it was reported that the physician ran a system diagnostic test and received high impedance. The patient was referred to the surgeon. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2016 the patient underwent a full revision. The surgeon first just replaced the generator but high impedance was still observed. The surgeon decided the left side was too scarred so he proceeded with right sided implant of the lead and generator. The old leads were cut with less than 2 cm of lead with electrodes left on the nerve. The explanted devices were requested for return but they have not been received to date.

 
Event Description

On (b)(6) 2016 it was reported that the explanted device cannot be returned for product analysis as the hospital requires a patient signed release.

 
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Brand NameLEAD MODEL 304
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 Key5297166
Report Number1644487-2015-06741
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 11/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number304-20
Device LOT Number3038
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/23/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/27/2011
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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