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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 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 08/02/2017
Event Type  Malfunction  
Event Description

It was reported that the patient's device was showing high impedance before a prophylactic generator replacement. During the surgery, the lead was pulled from the old generator and reinserted to rule out a pin insertion issue. High impedance was still observed after reinserting the pin. The generator was explanted and generator diagnostics were performed to rule out a generator malfunction. The generator diagnostics were ok, so the surgeon went forward with the lead replacement. When the surgeon went to remove the lead, it was noted that there was a lot of scar tissue. The lead also appeared to be hanging off the nerve by only the top electrode. The lead and generator were replaced. Further information was received from the physician that high impedance had been observed at a clinic visit prior to the referral for generator replacement and the high impedance was thought to have been caused by a lower battery. The products have not been received by the manufacturer to date. No additional relevant information has been received to date.

 
Event Description

The explanted lead and generator were received by the manufacturer. Product analysis has not been completed to date.

 
Event Description

Generator analysis was completed. There were no other issues noted and the generator passed the final test for the m102 devices. No abnormal performance or any other type of adverse condition was found with the generator. Lead analysis was also completed. There was a significant portion of the lead not returned including the section which contained the manufacturing id making it impossible to verify the serial number. There was only one returned portion of the lead returned which did not contain the pin or the electrodes. The segment returned contained the anchor tether and was cut right above that. A coil break was noted and believed to be the negative coil. Sem was performed on the lead break observed which showed that pitting or electro-etching conditions occurred. The broken coil appears to be caused by a fatigue fracture. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
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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 Key6851648
Report Number1644487-2017-04425
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/10/2017
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 Date02/29/2012
Device MODEL Number302-20
Device LOT Number2296
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/23/2009
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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