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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/01/2014
Event Type  Malfunction  
Event Description

Analysis of the returned generator was completed. 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. 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 an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed the device¿s battery voltage decreased from 2. 772v on (b)(6) 2014 to 2. 59v on (b)(6) 2014. Using the generator battery longevity table at the patient¿s last known programmed settings on (b)(6) 2014, the approximate battery life from beginning of life (bol) to end of service is 1. 9 years.

 
Event Description

Addendum product analysis was completed and approved on (b)(6) 2015: additional testing was requested on the pulse generator to monitor the battery status and voltage calculation. The pulse generator was re-assembled with the original battery. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Interrogation and system diagnostic tests were performed at various intervals in order to monitor battery and ifi status. Results of the additional testing indicate that the pulse generator is reading the battery voltage properly. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: follow-up report #7 inadvertently listed incorrect date received. Date should have been 05/11/2015.

 
Event Description

The explanted generator has been returned to the manufacturer where analysis is currently underway. An implant card was received indicating that the generator replacement surgery was prophylactic due to ifi = yes.

 
Event Description

It was reported that the patient's generator showed ifi = yes upon interrogation. The physician indicated that this was not expected as the generator was just implanted in (b)(6) 2013. It was reported that the patient was admitted over the weekend for seizures. The physician reported that a system diagnostic test was ok and that the patient has been ok since generator replacement. The physician believes that something may have happened after the surgery. Clinic notes dated (b)(4) 2014 note that the ifi is on. It was later reported that the surgeon is refusing to take the patient back for surgery as he does not believe there is anything that he could have done to warrant the patient to go back in for surgery. The surgeon reported that electrocautery is not used on the generator.

 
Event Description

Additional programming and diagnostic history was received on (b)(4) 2014. Review of the available programming and diagnostic history confirmed ifi = yes upon interrogation on (b)(4) 2014. Additional information was received from the surgeon stating that electrocautery was used only to open up the generator pocket to explant the previous generator during the generator replacement surgery that occurred in (b)(6) 2013. Diagnostic results with the replacement generator and the existing lead revealed normal device function when tested both inside and outside of the generator pocket. The surgeon noted that he did not use electrocautery after the replacement generator was implanted. Review of the device data revealed the device's battery voltage decreased from 3. 281v on (b)(6) 2013 to 2. 772v on (b)(6) 2014, indicating there was a drop of battery voltage that occurred in between these office visits with no other contributory factors such as increased lead impedance. The patient was referred for surgery by his neurologist to have the device replaced, primarily because the patient was experiencing an increase in seizures and the ifi condition of the device. There were no changes to medication which may have caused or contributed to the increase in seizures. Surgery has not occurred, and no known interventions have occurred to date.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
Event Description

It was reported that the patient was seen on (b)(6) 2014 and that the device is still showing ifi = yes. It was reported that the patient is high functioning and is of a personality that is "mischievous". The physician reported the patient experienced an increased level of seizure activity with no medication changes. It was reported that the neurologist would like to wait about three months and to reassess the patient at that time. However, it was reported that the surgeon is anxious to get the generator replaced due to situation and wanting to know what happened with the device. It was later reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2014. The generator is expected to be returned for analysis, but has not been received to date.

 
Event Description

It was reported that during additional testing of the generator, diagnostics have been performed each week and all behavior has been as expected. The original battery was reattached and battery voltage measurements have been taken showing nothing out of the ordinary.

 
Event Description

Additional analysis was completed on the generator on 01/27/2015. The generator was opened for additional testing. The battery voltage measured 2. 855 volts with the module attached to the battery. The current drain was 3. 22 micro amps. No visual anomalies were noted during visual examination. The battery voltage and the input to the a/d, that measures the battery voltage, were assessed while performing a vbat test. The battery voltage measured 2. 765 and the input measured 934mvolts. The input measured approximately one-third of the battery voltage, which according to design indicates the properly level for the input to a/d. All testing was performed at room ambient temperature. The module was removed from the battery and connected to a power supply. Vbat measure tests were performed with the power supply set to various voltages between 2. 0 and 3. 0 volts (the vbat trim values had not been changed from the as received values). Results of testing indicate that the vbat measurements are being read correctly by the module. The post burn-in electrical test results show that the pulse generator module performs according to functional specifications. Summary: results of testing indicate that the module is reading the battery voltage properly. No excessive current drain was noted when the current drain was measure while attached to the battery or during post burn-in test.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3661074
Report Number1644487-2014-00593
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2015
Device MODEL Number103
Device LOT Number202496
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/02/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2014 Patient Sequence Number: 1
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