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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 08/23/2016
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported by the physician's office that high impedance was observed with the patient's vns device. It was noted that due to the high impedance, the output current delivered to the patient was less than the intended programmed settings. It was later noted by the physician's office that x-rays were taken an came back negative. The patient was referred for surgery; however, no known surgeries have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported the patient had both his lead and generator replaced on (b)(6) 2016 due to high impedance. After the patient was replaced, his vns was checked and it was confirmed that his device was working as intended with an impedance value of 1939. It was later confirmed by the physician that the patient's pain over the generator site was due to the high impedance observed prior to the vns revision. The device is not expected to be returned as the explanting facility will not return to the manufacturer.

 
Manufacturer Narrative

This information was inadvertently left off of the initial mfr. Report.

 
Event Description

Clinic notes were received and it was noted the patient had voice alteration with stimulation; therefore, the settings were adjusted to try to resolve the voice alteration. The voice alteration appeared to begin at the same time as the high impedance occurred. Additionally, it was noted the patient was having a sharp pain over his generator periodically and sometimes with movement of his arm.

 
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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 Key5965755
Report Number1644487-2016-02144
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 08/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2015
Device MODEL Number304-20
Device LOT Number3061
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2011
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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