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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 304 GENERATOR Back to Search Results
Model Number 304-20
Device Problems High impedance; Output Problem
Event Date 09/17/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that low output current and high impedance was identified during interrogation of a patient. The patient's settings were adjusted, which temporarily resolved the low output current, but the high impedance was still present. X-rays were taken, but the cause of the high impedance could not be identified. The patient also reported feeling mildly painful stimulation one time at the generator site and itching at the neck during interrogation. The patient's device was programmed off until the cause of the high impedance, itching, and pain could be identified and fixed. Surgery to determine the cause of the high impedance is expected, but has not occurred to date.

 
Manufacturer Narrative

Brand name, corrected data: initial report inadvertently listed the wrong brand name of the suspect device. Model #, serial #, lot #, expiration date, corrected data: initial report inadvertently listed the wrong model, serial number, lot number, and expiration date of the suspect device. Manufacture date, corrected data: initial report inadvertently listed the wrong manufacture date of the suspect device.

 
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Brand NameLEAD MODEL 304
Type of DeviceGENERATOR
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 Key5150483
Report Number1644487-2015-06108
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Followup
Report Date 09/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2016
Device MODEL Number304-20
Device LOT Number3504
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/26/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/14/2015 Patient Sequence Number: 1
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