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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 11/10/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient wanted to get her vns removed. She stated that she doesn¿t think it¿s working anymore. She says it worked and helped her in the beginning, but stopped working for her later on and has been that way for a while. Information was received that the patient¿s device was fully explanted. The explanted generator and lead were received for analysis. Product analysis for the generator was completed and approved. During the analysis, there was no indication from the device that an end of service condition existed. The device output signal was monitored for more than 24-hrs, while the 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. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Product analysis on the lead was completed and approved. During the visual analysis of the returned 42mm portion quadfilar coil 1 appeared to be broken approximately 9mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. Pitting and residual material was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. No other obvious anomalies were noted. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity with the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional information has been received to date.

 
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Brand NameLEAD MODEL 302
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 Key8125705
Report Number1644487-2018-02194
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/22/2009
Device MODEL Number302-20
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/28/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/23/2006
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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