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Model Number 103
Event Date 12/24/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient experienced a shocking sensation in his chest that lasted approximately five minutes after walking through a metal detector. The shocking sensation occurred later once more but otherwise the patient was not having any pain. It did not occur during normal stimulation on-times. Follow-up revealed that the patient was unable to tolerate stimulation on-times from his device even at low device settings and was experiencing pain in his chest. No further information relevant to the event has been received to date.

Event Description

Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The septum was cored but no bodily fluid remnants were observed in the header septum cavity. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative

Manufacturer Narrative

Adverse event and/or product problem; corrected data. Supplemental mdr #01 inadvertently did not update this field with the additional information that was received. This report is being submitted to correct this data. Outcomes attributed to adverse event; corrected data. Supplemental mdr #01 inadvertently did not update this field with the additional information that was received. This report is being submitted to correct this data.

Event Description

Additional information was received stating that the vns patient was referred for surgery. The patient underwent generator replacement surgery on (b)(6) 2015. Preoperative and postoperative diagnostic results showed normal device function. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description

Follow-up with the physician¿s office revealed that the patient was seen in (b)(6) 2015 following generator replacement surgery. The patient was doing well and no issues were noted.

Event Description

The patient reported on (b)(6) 2016 that he believed that the generator was turned on (magnet mode only) because the generator was activated by the detectors at the doors of a large retail store, which caused the patient to have painful stimulation from his left neck to his ear, which made him drop to the floor. His stitches also came out because of the fall to the floor. The patient and his mother believed that the device was defective due to the electro-magnetic interference with the device. The patient had the generator explanted due to the painful stimulation, and the patient reported that the generator was analyzed by a vns technician that was certified by the state and had documentation that the device was defective. The patient did not know where the analysis was done. However, the device was returned to the manufacturer and analysis was performed. There were no anomalies identified with the generator other than the septum being cored. There was no bodily fluids inside the septum, though, so there would not have been a path for stimulation to reach the patient body. The patient also reported feeling the painful stimulation in the neck and ear, which is not near the patient generator. Therefore, the painful stimulation can reasonably assumed to not be related to the cored septum. The device performed according to specifications. No further relevant information has been received to date.

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
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 Key4430571
Report Number1644487-2015-03658
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2016
Device MODEL Number103
Device LOT Number202938
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/03/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/20/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 01/19/2015 Patient Sequence Number: 1