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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

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CYBERONICS - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problems Corroded ; High impedance; Mechanical Problem
Event Date 05/15/2012
Event Type  Malfunction  
Event Description

Patient underwent generator and lead explant surgery due to lack of efficacy. The devices were returned for analysis. In the 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. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In the lead assembly returned for analysis, an abraded opening was noted on the silicone tubing resulting in portion of the positive coil being exposed. Scanning electron microscopy images of the connector pin and connector ring show that pitting or electro-etching condition have occurred on both the connector pin and connector ring exposed surfaces. An energy dispersive spectrometry analysis was performed on a sample of the deposits observed on the pin. The analysis showed the presence of elements present in stainless steel 316. The higher percentage of iron in this sample suggests oxidation may have occurred. Though it is difficult to state conclusively the observed condition of the connector pin mentioned above may confirm this to be a contributing factor for the reported ¿high impedance¿ allegation. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Internal investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e. G. Sn<20000). As a result of this charge imbalance and the low pitting potential of quadfilar coil, coil corrosion can occur resulting in a lead discontinuity.

 
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Brand NameLEAD MODEL 303
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 Key8078971
Report Number1644487-2018-02072
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/30/2015
Device MODEL Number303-20
Device LOT Number2940
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 Received10/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/2011
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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