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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
Device Problem High impedance
Event Date 06/27/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that a vns patient's device was showing high impedance on diagnostics. The patient was sent for x-rays and referred to surgery. Follow-up from a company representative revealed that after reviewing the x-rays, it appeared that the lead pin was not completely inserted into the generator. No known surgery has occurred to-date.

 
Event Description

The patient's device was programmed off after the observance of the high impedance. The patient felt stimulation differently prior to the detection of the high impedance. X-rays were received by the manufacturer and review of the images determined the lead pin was fully inserted. There is a portion of the lead that is located behind the generator and was unable to be assessed. Surgery occurred on (b)(6) 2015. The generator was programmed off. Diagnostics showed the lead impedance was >10,000 ohms and the battery status was ifi, no. A replacement generator was connected to the old lead. Diagnostics were performed and the lead impedance was reported as high. The lead was then replaced, but was implanted on the right vagus nerve as the left nerve was observed to have too much scar tissue. Diagnostics on the replacement generator and the replacement lead were within normal limits. The explanted products have not been received to-date.

 
Manufacturer Narrative

Event description, corrected data: the information from the implant card received on 09/02/2015 was inadvertently not included on supplemental report #1.

 
Event Description

The explanted generator and lead have been received for analysis. Analysis is complete for the generator, but the lead is still pending analysis. Analysis was completed for the generator on (b)(4) 2015. Review of the data downloaded from the generator shows an indication of increased impedance, with an initial value of 2,239 ohms, increasing to a value of 13,000 ohms, on (b)(4) 2015. The septum was not cored. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An implant card was received, indicating high impedance on the lead and visible fluid in the lead observed during surgery. The generator was reported to have been replaced prophylactically.

 
Event Description

Analysis was completed for the returned lead portions. Lead fracture and fluid leaks due to a breach in the outer tubing wall were confirmed. An inner tubing wall breach was not identified. The electrodes were not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The coil appeared to be broken near the electrode bifurcation. Scanning electron microscopy identified the area on one of the broken coil strands as having evidence of a fatigue stress induced fracture with mechanical damage and pitting. Two of the broken coil strands were identified as being mechanically damaged with smooth surfaces, which prevented identification of the coil fracture type. The remaining broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Abraded openings that were 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 found inside the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions 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 other discontinuities were identified.

 
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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 Key4950460
Report Number1644487-2015-05362
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup,Followup
Report Date 07/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2014
Device MODEL Number304-20
Device LOT Number2786
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/08/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2010
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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