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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 Problem Fracture
Event Date 11/09/2017
Event Type  Malfunction  
Event Description

It was reported that high impedance was observed on the patient's device. It was also stated that the patient experiences pain during stimulation at times in the neck and chest. The patient was referred for consult with the surgeon however no surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

 
Event Description

Additional information was received from the physician that the high impedance was observed upon interrogation of the vns device during a clinic visit. It was stated that the patient constantly touches the unit which could be a potential cause for the observed high impedance. The patient had a full revision surgery and the explanted lead and generator were returned for analysis however analysis has not been completed to date. On the date of replacement the impedance was noted to be ok however based on the position of the patient it could have shown to be ok so the device was replaced regardless.

 
Event Description

Product analysis was completed on the returned generator and lead. Generator analysis revealed there were performance or any other type of adverse conditions found with the pulse generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Lead analysis was completed. The lead was returned in one piece which did not include the electrodes. There were two set screw marks noted on the connector pin indicating that at one point in time proper contact existed between the set screw and the connector pin. The negative coil was kinked at one location and was also punctured at a separate location. Although, not conclusive, it appears this observed punctures are the result of the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Since the electrodes were not returned as well a full evaluation of the entire lead could be performed so a failure in that section of the lead could not be ruled out.

 
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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 Key7081841
Report Number1644487-2017-04928
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/05/2008
Device MODEL Number302-20
Device LOT Number1164
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/07/2005
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: 12/04/2017 Patient Sequence Number: 1
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