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Model Number 103
Device Problem Migration or Expulsion of Device
Event Date 10/30/2014
Event Type  Injury  
Event Description

It was reported that in two weeks since the patient¿s vns surgery, she has made a complete turnaround. It was noted that she has not had any seizures and her father feels that the seizures were due to hormonal changes occurring due to puberty. She will likely not be re-implanted and will instead continue medications.

Event Description

Initially, it was reported that the patient was seen in the emergency room with complaints of device migration and painful device stimulation. The patient was seen on (b)(6) 2014 to program the device off while the issues were being addressed. A chest x-ray confirmed proper positioning of the device. The nurse practitioner indicated that there is no belief that the reported issues are related to vns. It was later reported that the pain occurred approximately three times a day for approximately thirty minutes each occurrence. It was also reported that the patient has lost twenty pounds which caused the device migration. The device output current was decreased from 2. 25 ma to 0. 50 ma and then later programmed off. The patient continued to report pain despite the device being programmed off. The patient';s father reported that the patient was scheduled for vns explant due to her discomfort and pain with the migration. It was reported that the vns has helped with the patient's seizures, but that the generator would not be replaced for now. The physician reported that the surgery was being performed for patient comfort. The patient's generator was explanted. No additional relevant information has been received to date.

Manufacturer Narrative

Event Description

The patient's generator was returned for analysis on 01/21/2015. Product analysis for the generator was completed and approved on 02/17/2015. In the product analysis 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, 2. 936 volts as measured during completion of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

On (b)(6) 2015 it was reported through clinic notes dated (b)(6) 2015 which indicate that the patient is considering re-implant of the vns device after having it removed due to irritation in (b)(6) 2014. Although re-implant surgery is likely, it has not occurred 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 Key4338510
Report Number1644487-2014-03379
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/01/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2012
Device MODEL Number103
Device LOT Number201595
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 12/17/2014 Patient Sequence Number: 1