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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 06/30/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

During review of the in-house programming/diagnostic history database, it was observed that low impedance was observed at office visit on (b)(6) 2015. A subsequent diagnostic test was performed during the same visit and resulted with normal impedance levels. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the low impedance reading. Review of the programming data that captured the low impedance found that when the low impedance message presented the actual impedance value was measured as 384 ohms. Further follow-up found that the generator was still presenting with a low impedance message during a visit on (b)(6) 2016. No surgical interventions are known to have occurred to date.

 
Manufacturer Narrative

 
Event Description

It was reported that the patient was experiencing a funny sensation in the neck and throat; which was attributed to vns stimulation. This change in perception was noted at the same time that the low impedance was observed and therefore appears to be related. The patient was referred for a lead and generator replacement however no surgical interventions are known to have occurred to date.

 
Event Description

The patient underwent vns lead and generator replacement surgery. In pre-op, diagnostic testing resulted within normal limits. During surgery the surgeon observed approximately 1 inch of the lead insulation was stripped off of the lead. The missing piece of the lead insulation could not be located. The lead and generator were then explanted and later received by the manufacturer. Both products are currently pending product analysis.

 
Event Description

Product analysis on the generator was completed. During analysis the output signal of the generator was monitored for more than 24-hrs and no variations in the output signal or expected level of output current were observed. The generator performed to functional specification.

 
Event Description

Product analysis was completed on the received lead portions. It was noted that the portion of the lead with the electrodes was not received therefore a complete evaluation could not be performed on the entire lead. The lead was received in 4 portions with the segment containing the lead connector pin still inserted into the generator. A continuity measurement verified electrical and mechanical contact between the generator and the lead pin. X-rays were taken and revealed that the canted spring of the generator was making contact with the connector ring of the lead. The continuity of the lead portions were evaluated and no discontinuities were identified within each portion. During analysis it was observed that the outer and inner silicone tubing had abrasions which would have made it possible for the quadfilar coils to come in contact with each other which would have caused a short circuit condition that would result in low impedance. Bodily fluids were observed inside the inner and outer tubing and coil fractures were observed in multiple areas however pitting was not observed. Analysis determined that the mechanism for some of the fractures appeared to be stress induced. However the mechanism for all of the fractures could not be determined. Based on the results of analysis it appears that the cause of the low impedance is related to a short circuit condition in the lead.

 
Event Description

It was reported that the patient experienced discomfort when the lead and generator were implanted.

 
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Brand NameLEAD MODEL 304
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 Key5896715
Report Number1644487-2016-01907
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 11/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number304-20
Device LOT Number201579
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/22/2010
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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