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Model Number 103
Event Date 05/01/2012
Event Type  Injury  
Event Description

Clinic notes were received for the patient's prophylactic generator replacement surgery since the patient's device was at ifi=yes. During the review of the clinic notes dated (b)(6) 2012, it was observed that the patient an improvement in seizure control until the prior few weeks when her seizures again increased so for no apparent reason. Her seizures decreased to three to four per day after depakote was increased to the current dose at her last office visit. As noted on (b)(6) 2012, she had an average of five to six seizures per day. Most of the seizures were generalized tonic-clonic seizures lasting approximately one minute. Swiping the vns magnet is not helpful for these seizures, and these seizures are associated with cyanosis. The atonic seizures remained decreased and were occurring three to four times per month, as opposed to daily prior to the last increase in depakote on (b)(6) 2012. The patient has increased seizures during her menses, and the patient had not recently been ill. The physician noted that the vns was nearly at end of service, but continued to deliver stimulation. It is possible that she is not receiving the full output current due to gradual depletion of the generator thus the increase in seizures. Although she has never been seizure-free post vns implant, the patient's mother feels the vns has been efficacious and wished to have generator replacement as soon as possible. No changes were made to the vns settings on this visit. The patient had generator replacement on (b)(6) 2012, however, attempts for product return have been unsuccessful to date.

Event Description

Product analysis for the generator was completed. 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. The reported ifi=yes was duplicated in the lab. Results of bench diagnostic testing indicated the device was operating properly with ifi yes. The data in the diagaccum consumed memory locations revealed that 96. 675% of the battery had been consumed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage value stored within the generator suggests an ifi battery partially depleted condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative

Event Description

Additional information was received from the nurse practitioner indicating that the increase in seizures was not back to pre-vns seizure frequency but it was increasing. It was believed to be due to the loss of vns therapy. The patient's cyanosis is not related to vns therapy. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase seizures. The clinical symptoms have improved since generator replacement on (b)(6) 2012. The patient's tonic seizures were not previously aborted by magnet stimulation prior to (b)(6) 2012. The generator was received by the manufacturer; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as battery depletion.

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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2697513
Report Number1644487-2012-02027
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/17/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number103
Device LOT Number200746
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/23/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/11/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 08/14/2012 Patient Sequence Number: 1