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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 04/29/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, it was reported that high impedance was observed for this patient (impedance; 10. 000 ohms). The patient was recently implanted, and no trauma/manipulation was reported. The device was not disabled. X-rays were taken but have not been received. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

Event Description

Clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient was seen and complained of a vns system malfunction of high impedance. The patient felt he was not improving.

Event Description

Additional information was received that the patient had generator and lead replacement and the explanted product were returned to the manufacturer for evaluation. When received, the ram and flash data were downloaded from the generator. The data in the diagaccumconsumed memory locations revealed that 3. 456% of the battery had been consumed. Visual examination showed tool marks on the pulse generator case and header most likely associated with manipulation of the device during the explant procedure. Burn marks were observed on the pulse generator case indicating that the pulse generator may have been exposed to an electro-cautery tool. The septum was not cored. No other surface abnormalities were noted on this device. An interrogation and system diagnostics test were performed, with a one inch spacer between the generator and the programming wand. Resulting status checks for; communication were ok, lead impedance and current delivered were normal for all diagnostic tests performed. The generator was subjected to and successfully completed a final electrical test. The generator is operating within specification. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 974 volts as measured shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 3. 456% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator. The lead was returned for the allegation of explanted due to high lead break/high impedance. No obvious anomalies were noted. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The lead assembly was returned in two portions and the tie downs were not returned. On the returned 4234mm portion, setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. Continuity testing could not be performed during the decontamination procedure because the returned lead was not connected to a generator when received into pa. Incisions were made to allow for continuity checks. Abrasions were observed on the inner silicone tubes, but did not penetrate. Incision marks were observed on the inner silicone tubes and the marks penetrated the insulation and the quadfilar coils appeared to be kinked, in these areas. No discontinuities were identified during the continuity check. An analysis performed on the returned lead portions did not confirm the allegation. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of explanted due to lead break/high impedance.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description

X-rays were received on (b)(4) 2013. The generator was seen in the left chest area in normal orientation. The filter feedthru wires appear intact and the lead appears intact at the connector pin. The lead pin could not be seen past the second connector block indicating that it may not be fully inserted into the generator. The electrodes were observed in the neck, but do not appear to be in proper alignment. In the images it appears that the electrodes are placed in the opposite alignment with the positive electrode on the bottom, followed by the negative electrode on top. The lead is routed upwards from the electrodes then down toward the generator. No gross discontinuities or sharp angles were observed in the portion that could be assessed. Clinic notes dated (b)(6) 2013 indicated that the patient was seen for vns system malfunction of a high impedance error. The patient did not feel that he was improving, the patient¿s vns incisions were well-healed. Surgery is likely but has not taken place.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected but did not cause or contribute to a death or serious injury.

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Brand NameLEAD MODEL 304
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3122782
Report Number1644487-2013-01361
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/29/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number304-20
Device LOT Number202180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/30/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/24/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial