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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 09/01/2012
Event Type  Malfunction  
Event Description

On (b)(4) 2013 it was reported that the vns patient had been experiencing 3-4 episodes of severe shortness of breath within the last 6 months. These events lasted approximately 30 seconds and she had great difficulty getting a full breath. She cannot reproduce these events and is unsure of any pattern or triggers that could possibly be causing these events. The patient also had a complaint of throat pain in (b)(6) 2012. At that time her settings were lowered. The patient's settings prior to the (b)(6) 2012 complaint of throat pain were output=1. 5ma/pulse width=250usec/frequency=20hz/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. After the (b)(6) 2012 visit, the patient's settings were changed to the following to alleviate the throat pain: output=1. 5ma/frequency=15hz/pulse width=130usec/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=130usec. The patient was interrogated during the (b)(6) 2013 visit, then a system diagnostics test was performed, and then upon second interrogation, the device showed an error message stating "programmed current is possibly not being delivered at the specified level (possibly limited by battery voltage, lead impedance, or other reason). Reprogram the pulse generator to a lower output current and a wider pulse width. " there was no impedance issues, output current errors, or elevate impedance values when running the diagnostics. The patient was re-programmed to a wider pulse width, from 130 usec to 250 usec, per the instructions of the error message (both normal output and magnet output) and the error seemed to resolve itself. No changes were made to the output current or the rest of the patient's settings. Diagnostics were performed again and all results were within normal limits. A final interrogation was performed without an issue. The patient left the clinical visit at settings of output=1. 5ma/pulse width=250usec/frequency=15hz/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. It was later clarified that the issue has resolved itself. Also, the patient's shortness of breath only happened 3-4 times over a 3-4 month span. It was unclear if the patient's pain and shortness of breath coincided with stimulation and if they had resolved. It was stated that x-rays were taken and would be sent to the manufacturer for review but they have not been received to date.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3079679
Report Number1644487-2013-01170
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 04/03/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number103
Device LOT Number201866
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/30/2011
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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