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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
Device Problems Device Displays Incorrect Message ; Handpiece
Event Date 04/03/2014
Event Type  Malfunction  
Event Description

Additional information was received stating that vns patient¿s device showed the pulse disablement message prior to the mri. The patient¿s device was programmed on back to her previous device settings after the mri. Attempts for additional relevant information, including a copy of the software flashcard, have been unsuccessful to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: additional information indicates that the warning message appeared prior to the mri.

 
Manufacturer Narrative

Corrected data (conclusion code): the supplemental 02 report inadvertently included the incorrect conclusions coding. The conclusion coding has been updated to no conclusion can be drawn.

 
Event Description

It was reported that the patient underwent generator replacement due to eos - yes. The explanted generator was received for analysis. The returned product form indicated that the generator was replaced due to neos - yes. The implant card was received also indicating that the generator was replaced due to battery depletion, near eos/ neos - yes. Analysis is underway, but has not been completed to date.

 
Event Description

A copy of the software flashcard was obtained. Programming and diagnostic history from the date of the mri was reviewed. Prior to the mri, the device was interrogated, disabled, and interrogated again. Following the mri, the device was interrogated and programmed back on. System diagnostic results performed on that day revealed normal device function. Review of the decoder data confirmed that the generator was disabled due to vbat < eos threshold upon initial interrogation on the date of the mri. Review of the battery voltage from this date revealed 3. 065v from the last 24hr voltage measurement.

 
Manufacturer Narrative

Review of decoder data and programming and diagnostic history.

 
Event Description

It was reported that the vns patient¿s device was programmed off prior to having an mri. The nurse stated that when the device was programmed back on after mri, the handheld device displayed a warning message indicating ¿pulse disablement with vbat < eos threshold¿. After proceeding through the warning message, the battery icon was fully green and diagnostic testing performed revealed that the eos status was no and the lead impedance within normal limits (impedance value ¿ 2191 ohms). No adverse events were reported. No known interventions have occurred to date. Attempts to obtain additional information are in progress.

 
Event Description

Analysis of the generator was completed on 07/16/2015. 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 shows an ifi=yes condition. In the pa lab there were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder identified that the generator was at a near end of service.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key3782239
Report Number1644487-2014-01135
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number103
Device LOT Number201604
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/19/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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