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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction  
Event Description

It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.

Event Description

An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Manufacturer Narrative

Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.

Event Description

The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3027440
Report Number1644487-2013-00867
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2006
Device MODEL Number302-20
Device LOT Number010763
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/03/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/24/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/23/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 03/29/2013 Patient Sequence Number: 1