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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/01/2005
Event Type  Injury  
Event Description

It was reported that the patient had vns explant in 2006 due to cardiac episodes and painful stimulation. The patient had previously had generator replacement on (b)(6) 2006. Review of the generator programming history revealed that the device was programed off on (b)(6) 2007. The explant therefore occurred sometime after that time. The patient had vns re-implant surgery on (b)(6) 2014. During surgery, the surgeon noted that the old lead electrodes were inverted on the vagus nerve (with the positive and negative electrodes inverted). It was reported that in 2005, the patient had a cardiac episode and was hospitalized for bradycardia. Additionally, the patient had painful stimulation. As a result, the device was turned off, and the generator and a portion of the lead in the chest area was explanted. Review of programming history in-house reveals the device was programmed off on (b)(6) 2007. Follow-up with the patient's treating neurologist revealed that there is only limited information regarding the events, as the patient was treated by a different physician at the practice at the time of the events and that physician no longer works at the practice. The currently treating physician's recollection is that there were "big problems" with getting the patient regulated which would be explained by the inverted electrodes, per the physician. The explanted portion of the lead from surgery on (b)(6) 2014 was received by the manufacturer for analysis. Note that a large portion of the lead assembly (body); including the connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuity in the returned portion of the device which may have contributed to the stated allegations. Additionally for the explanted generator on (b)(6) 2006, analysis was completed. Based on the battery life analysis, the pulse generator approached a normal end of life condition. In addition, the pulse generator was operating at an increased duty cycle (71%) and, as defined in the physician¿s manual, this will deplete the battery faster than a low duty cycle; this may have been a contributing factor. The reported condition of erratic stimulation at that time was not verified in the laboratory. Delivered generator output across an electrical load confirmed a steady output voltage consistent with programmed parameter settings. There were no signs of variation in the output signal. The pulse generator would not interrogate, therefore was opened. The measured battery voltage was below the low battery operation level specified for the pulse generator, which indicates that the pulse generator had reached the end of life. These measurement in the lab demonstrate appropriate current consumption for the device, resulting in normal battery depletion. No performance anomalies were noted.

Event Description

The surgeon's office reported that the patient had explant surgery on (b)(6) 2008. It was also reported that the explanted generator and portion of the lead explanted at that time were discarded.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. However, lead electrodes were noted to be inverted on the nerve.

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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key4233217
Report Number1644487-2014-02955
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Type of Report Initial,Followup
Report Date 10/14/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2004
Device MODEL Number302-20
Device LOT Number7083
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/16/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/10/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/24/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 11/06/2014 Patient Sequence Number: 1