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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 Problems Low impedance; Device Displays Incorrect Message
Event Date 11/06/2015
Event Type  Malfunction  
Event Description

It was reported by the physician that the patient no longer feels stimulation. It was also reported the physician received the low impedance <600 ohms warning when interrogating the device. The patient was referred to a consultation for a full revision and replacement of the vns system. It was also reported the patient is severely mentally retarded and developmentally delayed. The patient is also prone to violent outbursts.

 
Event Description

It was reported the patient is a poor historian and the date of initial onset for the inability of the patient to perceive stimulation is not known. Additionally, it was reported there was no known trauma or incident suspected that could have caused or contributed to the reported event. No additional relevant information has been received to date.

 
Event Description

It was reported the patient underwent lead and generator revision surgery on (b)(6) 2016. Pre-operative testing of the vns verified the low impedance previously observed. The physician put a new generator on the existing lead and found 615 ohms. The decision was made to removed and replace the lead. It was found during surgery the electrodes were not on the nerve and there was no strain relief loop or anchor tethers present. The new lead was placed on the nerve, tethered and connected to the new generator. Diagnostics were performed and showed 2155 ohms. There was no known trauma or manipulation that could have caused the lead to come off of the nerve; however, the patient is autistic and combative. No additional relevant information has been received to date.

 
Event Description

Product analysis for the returned generator was completed. The generator output signal was monitored for more than 24 hours while in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The battery voltage measured during analysis showed an ifi = yes (intensified follow-up indicator) condition. There were no performance or any other type of adverse conditions found with the generator.

 
Event Description

Pa for the returned lead portion was approved on (b)(6) 2016. The lead was found to have abraded openings on the outer and inner silicone tubing of the lead coils. Also, the positive and negative lead coils have what appear to be wear (flat surfaces) at the exposed portions located past the electrode bifurcation. The reported ¿low impedance¿ allegation was not verified. Though it was difficult to state conclusively, the identified exposed coil portions at the silicone tubing abraded openings may confirm this to be a contributing factor for the reported low impedance/short circuit condition. However, the exact point in time when the short occurred is unknown. Note that 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.

 
Event Description

It was also observed, during lead product analysis, that the lead connector boot had partial detachment at the ring/backfill interface. The reason for this condition was unknown.

 
Manufacturer Narrative

Describe event or problem; corrected data: this information was inadvertently left off of the supplemental #04 mfr. Report.

 
Event Description

The lead assembly had dried remnant of what appeared to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

 
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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 Key5257603
Report Number1644487-2015-06615
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 11/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2009
Device MODEL Number302-30
Device LOT Number200252
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2006
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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