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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 Problems Corroded ; Fracture; Mechanical Problem; Low impedance
Event Date 04/11/2017
Event Type  Malfunction  
Event Description

It was reported that during an office visit a diagnostic test was performed and resulted in low impedance. It was also reported that the patient had been experiencing an increase in seizures and a change in behavior which both appeared to be related to the low impedance. X-rays were performed and reviewed by the manufacturer. However due to the poor quality of the images provided the integrity of the lead was difficult to assess. Therefore the cause of the low impedance could not be determined. The patient was then referred for surgery where the lead and generator were replaced. The explanted products have not been received to date.

 
Event Description

The generator and lead were received by the manufacturer. The generator product analysis was completed. Visual analysis noted signs consistent with generator manipulation during explantation. The device was noted to be at ifi = no. The results were expected for all diagnostic tests in which various impedance loads were applied to the generator. The output signal of the generator was monitored for a 24 hour period and there were no variations in the output. The device performed to specification. The lead is pending product analysis.

 
Event Description

Analysis was completed on the lead. The lead was received in two portions of tubing with 3 loose quadfilar coils. Set screw marks confirmed that at one time there was adequate connection between the lead pin and generator. Visual analysis observed several abraded openings in the inner & outer tubing that appeared to be caused by wear. These confirmed openings were in adjacent areas and the exposed conductive quadfilar coils created a potential short-circuit condition thus confirming the report of low impedance. Additionally, lead fractures were observed in various locations. Some fractures appeared to be caused by the explant procedure while others appeared to have been caused by mechanical fatigue. Pitting was observed at some fracture sites, indicating that the stimulation was still be provided after the fracture occurred. It was noted that the three loose strands of coil each had melted ends indicating they were exposed to electrocautery during the explant procedure.

 
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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 Key6563365
Report Number1644487-2017-03773
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number304-20
Device LOT Number202115
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2012
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: 05/12/2017 Patient Sequence Number: 1
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