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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

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CYBERONICS - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-30
Event Date 07/29/2015
Event Type  Malfunction  
Event Description

It was reported on (b)(6) 2015 that a low impedance warning message was seen on a patient's device upon interrogation. This was the patient's first appointment after battery replacement on (b)(6) 2015. It was noted that after the replacement, diagnostics were taken and came back in range. It was then noted that following a running of the system diagnostics the impedance resulted in range, 1692 ohms. The decoder information from generator was received and indicated that the impedance values were fluctuating from normal impedance values back to low impedance values and then back to normal impedance. Based on these impedance values it is clear that there is a short in the circuit causing the impedance to fluctuate between normal and low readings. This is likely due to wear on the lead based on the age of the device. While surgical intervention is likely, no surgery has been planned or scheduled to date.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5048038
Report Number1644487-2015-05678
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 08/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number303-30
Device LOT Number201776
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/19/2011
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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