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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 04/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient began experiencing pain in her chest during stimulation on-times after falling into a glass table. The pain resolved when the magnet was used to temporarily disable the device. The device was programmed off during an office visit on (b)(6) 2014. Diagnostic results did not indicate any issues with the patient¿s device. The patient previously reported occasional tightness in her chest, erratic stimulation and stimulation on-times not perceived. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Additional information was received that the patient underwent replacement of the generator and lead on (b)(6) 2014. The portion of the lead that was explanted was discarded by the explant facility. The explanted generator was received on (b)(6) 2015. In the pa lab, 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, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. During the product analysis, there were no anomalies found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 102R
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 Key4262629
Report Number1644487-2014-03081
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2014
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 Number102R
Device LOT Number200776
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2008
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: 11/19/2014 Patient Sequence Number: 1
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