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Model Number 103
Event Date 12/09/2014
Event Type  Malfunction  
Event Description

It was reported that during initial implantation surgery, the surgeon connected the lead to the patient's vagus nerve and then connected the lead to the generator prior to tunneling the lead to check the lead impedance. The impedance was within normal limits (1979 ohms) so the surgeon attempted to disconnect the lead pin from the generator header to tunnel the lead under the patient's skin; however, the surgeon was unable to disconnect the lead from the generator. The surgeon removed the lead electrodes from the patient's vagus nerve and then retrieved a new generator and lead to implant. No difficulties were experienced with the newly obtained generator and lead and the patient was successfully implanted. It was reported that another attempt was performed to disconnect the lead pin from the generator header; however, this was again unsuccessful and during the attempt the lead was broken. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

Event Description

Product analysis for the generator was completed and approved. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. A model 302 and 304 bench lead were inserted completely past the negative and positive connectors and was removed with no difficulties. Other than the noted conditions with the septum and test resistor, which are most likely related to user damage, there were no adverse functional, mechanical, or visual issues identified with the returned generator. Product analysis for the lead was completed and approved. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the 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, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative

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

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Type of DeviceGENERATOR
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 Key4391101
Report Number1644487-2015-03533
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number103
Device LOT Number203000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial