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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 302-30
Device Problem Low impedance
Event Date 07/09/2015
Event Type  Malfunction  
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
Event Description

On (b)(6) 2015 a physician asked whether low impedance in diagnostic testing (60;600) is suggestive of a short circuit. The physician later reported that he does have a patient with low impedance. This low impedance was first observed on (b)(6) 2015 on a system diagnostics test. The physician did not make any changes to the patient's settings at that time. The physician indicated that the patient has an intellectual disability and therefore is unable to express any change in stimulation perception, but that the patient's seizures have been increasing since her last visit in (b)(6). Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2015 the patient's generator product information was provided by the implanting facility.

 
Event Description

It was reported that the patient is having an evoked potential test.

 
Event Description

On (b)(4) 2015 it was reported that the patient underwent a full revision surgery that day. Attempts were made for the return of the explanted products but they have not been received to date.

 
Event Description

On (b)(6) 2015 the explanted generator and lead were received for product analysis. Product analysis has been completed on the generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In the product analysis lab, 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. 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. Product analysis is still underway on the leads and has not yet been completed.

 
Event Description

Product analysis was completed on the leads on 1/25/2016. The majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer and in one area of the connector ring inner silicone tubing. The quadfilar coil appeared to be stretched and exposed. The abraded openings 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. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.

 
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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 Key4932439
Report Number1644487-2015-05288
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 07/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/06/2006
Device MODEL Number302-30
Device LOT Number010850
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/29/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/07/2004
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: 07/22/2015 Patient Sequence Number: 1
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