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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302
Device Problems Corroded ; Fluid Leak; Fracture; Low impedance
Event Date 01/31/2016
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the physician performed a diagnostic test during a visit and observed a low impedance warning. Chest x-rays were reviewed by the physician and a lead fracture was observed. These images have not been reviewed by the manufacturer to date. It is unknown if the patient sustained an injury which could have caused the lead fracture. The device was programmed off and the patient was referred for surgery. No surgical interventions are known to have occurred to date.

 
Event Description

It was reported that the patient underwent lead and generator replacement surgery. The explanted products have not been received to date.

 
Event Description

The explanted lead and generator were received. Both are currently pending analysis.

 
Event Description

Analysis was completed on the returned generator and lead. During testing the generator performed to functional specification and no anomalies were observed. The internal data of the generator was reviewed and confirmed that a low impedance had occurred while implanted. The lead was received in 5 segments which included the lead pin and electrodes. There were set screw marks on the pin which indicated that there was good contact between the lead and generator at one time. Abrading openings were found in the inner and outer tubing in various locations in the lead. Scanning electron microscopy was used to evaluate the lead and found broken coil strands with evidence that the fracture was stress induced from fatigue and rotational forces. There was evidence of pitting on one coil strand which indicates that the fracture was present while stimulation was occurring. Additionally with the abraded insulation, it was found that a short condition was occurring between the coils. Analysis of the lead confirmed the short circuit condition which caused the low impedance.

 
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Brand NameLEAD MODEL 302
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 Key6852981
Report Number1644487-2017-04430
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2009
Device MODEL Number302
Device LOT Number1538
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/21/2006
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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