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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 12/01/2014
Event Type  Injury  
Event Description

The patient underwent a battery replacement on (b)(6) 2015. The device has not been received for analysis to date.

 
Manufacturer Narrative

 
Event Description

The patient's m103 device was returned for analysis on 02/12/2015. Product analysis of the generator was completed and approved 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, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a neos=yes condition. The electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event.

 
Event Description

It was reported that the vns patient was experiencing pain and arm jerking with stimulation on-times. The patient had also been having some increased seizure activity. The patient¿s device was tested and showed an end of service condition. It was noted that patient harms himself and that there was scarring at the neck. The patient was referred for surgery but no known surgical interventions have occurred 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 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 Key4377344
Report Number1644487-2015-03488
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 12/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date04/30/2011
Device MODEL Number103
Device LOT Number201114
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/10/2009
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: 01/02/2015 Patient Sequence Number: 1
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