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Model Number 104
Event Date 04/25/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, the hospital called to get information on returning the explanted device. It was found that the generator was explanted on (b)(6) 2013. The reason for explant was not provided; however, the implant card indicates that the generator was replaced due to battery depletion nearing end of service. The card stated that the lead impedance was ok, with a dcdc code of 2. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided. The explanted generator was returned on (b)(4) 2013 and is pending product analysis.

Event Description

Further follow-up revealed that the high lead impedance was resolved when the lead was reinserted into the generator header and the setscrew was retightened. Analysis of the generator was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. 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 battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Information was received which changes the suspect device.

Event Description

On (b)(6) 2013, the physician stated that during the interrogation of the patient's device, an error message kept appearing. He stated that he could not remember what the error message was, but he had spoken to the manufacturer's sales representative about it and interpreted the message as the patient's vns battery failing. Follow up with the manufacturer's sales representative found that the physician had indicated that he saw an ifi warning message. It was stated that the physician referred the patient for consult surgery and that surgery was planned. During surgery on (b)(6) 2013, the surgeon reported that he performed system diagnostics on the implanted device and got a >10,000 ohms message. The surgeon did not have an accessory pack to test the generator, but stated that he would remove the pin, and re-insert it to confirm that the issue was not the generator. The surgeon stated that he would attempt to resolve the impedance with a pin insertion, but would plan for a full revision if it did not resolve. It was confirmed that the surgery occurred; however, it is unknown if both the lead and generator were replaced or if it was just the generator. An attempt has been made to get additional information from the surgeon; however, it was unsuccessful. No additional information has been provided.

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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 Key3148057
Report Number1644487-2013-01690
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number104
Device LOT Number201142
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/25/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/10/1998
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial