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Model Number 103
Event Date 07/04/2011
Event Type  Malfunction  
Event Description

It was reported that the pt started feeling painful stimulation at generator site a few weeks prior. Pt's current setting are 2. 5/30/500/30/5 magnet 30/60/500. Diagnostics were performed and results were within normal limits, 2595 ohms, ifi: no. The green light showing battery consumption was showing half full and the physician does not think this is correct. Based on pt's current settings, the pt's device should last about 4 years and half green light means the battery has 25% to 50% remaining battery life which is not expected. X-rays of the pt's device were taken and reviewed by the mfr. No anomalies were seen on the x-rays. The physician ran diagnostics with pt's head turned different ways. When the head was turned to the right, the pt did not feel painful stimulation, but when the head was turned to the left, the pt felt the painful stimulation. Diagnostics in all positions were ok. The physician lowered the settings and the pain resolved. Attempts for further info have been unsuccessful to date.

Event Description

Further information reveals the patient has a consult for the painful stimulation issue and a decision will be made on how to proceed. Attempts for further information have been unsuccessful to date.

Event Description

Decoder spreadsheet analysis was performed for the patient's vns programming history. A review of patient programming data revealed that on (b)(6) 2011 the initial interrogation of the device resulted in a measured battery voltage of 2. 849v, indicating that a 25% battery status indicator was displayed to the user during this interrogation (e. G. 25% remaining is displayed at measured voltages of 2. 85v with demipulse generators). All subsequent communication operations resulted in a measured voltage of 2. 68v at the same programmed settings, based on charge accumulation this would have resulted in the expected 100% status indicator. Based on this data, it is possible that battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life. The manufacturer addressed this issue with demipulse generators by adding a 0. 5v offset to measured battery voltage during the first 7. 5% of battery consumption to mitigate the potential for artificially low voltage measurements during this period. The fact that the voltage measurement of 2. 894v was received at 9. 560% of consumption may indicate that battery impedance for this particular generator was longer than most (e. G. An outlier). Based on all subsequent programming data the device appears to be functioning as intended.

Manufacturer Narrative

Analysis of programming history. The battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life.

Event Description

Further manufacturer investigation revealed that the root cause of the observed battery voltage behavior has been determined to be the result of either an extended duration of the reduced conductivity (i. E. High battery impedance) experienced by cfx batteries during the beginning of life (bol) or a minute internal short that managed to "burn" itself out resulting in the observed voltage rebound following 10% of discharge (e. G. Consumption). No change to risk has occurred as a result of this investigation, which continues to be "low. " change request numbers (b)(4) were created as a result of this investigation. (b)(4) proposes that the duration of the 0. 5v offset, implemented by the firmware for model 103/104/105/106 generators be extended from 7. 5% to 15% of consumption within 11. X programming software in order to mitigate such events in the future. (b)(4) proposes that this issue be mitigated either through the firmware (as the device is still under development) or through the programming software as well.

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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 Key2245770
Report Number1644487-2011-01978
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/25/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2012
Device MODEL Number103
Device LOT Number201513
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/07/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial