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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 03/01/2013
Event Type  Injury  
Event Description

It was reported that the patient underwent generator and lead replacement surgery on (b)(6) 2013. It was reported that system diagnostics following the replacement were without error. It was reported that the generator was replaced prophylactically and the lead was replaced due to pain. The implant card was received which confirmed that both generator and lead were replaced on (b)(6) 2013. The implant card listed prophylactic replacement and that lead impedance was ok. Both generator and lead were received by device manufacturer on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. There were abraded openings found on the outer silicone tubing which most likely provided a leakage path for what appeared to be remnants of dried body fluids found in inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process. Except for the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. With the exception of the abraded tubing openings, no 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 check of the returned lead portions were performed with no discontinuities identified. Based on the finding in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the events. Since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the generator is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on (b)(4) 2013. Although the reported allegation of pain cannot be evaluated in the pa laboratory settings, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In additional, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data found that 8. 059% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Event Description

It was reported that the patient's device has been causing her pain. The notes revealed that the patient grabs at the lead during a seizure. The physician noted that there is a visual change in the appearance in the lead in her neck and that surgery is recommended. The physician reported that he believes the strain in the lead was caused by the patient grabbing at the lead during a seizure. Diagnostic tests were performed and were within normal limits. It was reported that the lead is uncomfortable for the patient. The physician reported that the pain is not due to vns and that it appears to have occurred due to patient manipulation. No causal or contributory medication changes preceded the onset of the events. The physician reported that the surgery was done to preclude a serious injury and for patient comfort. It was reported that the lead strain is around the patient's clavicle and that it is unknown if the surgeon used non-absorbable suture to secure the generator to the fascia during implantation per the neurologist. The physician indicated that the lead strain does not appear to be due to initial placement. The patient has not undergone any physiological changes that may have contributed to the lead strain. The patient has been referred for surgery; however, surgery has not occurred 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 Key3043863
Report Number1644487-2013-00965
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 03/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number302-20
Device LOT Number010388
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/25/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/17/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 04/09/2013 Patient Sequence Number: 1