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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 12/10/2014
Event Type  Injury  
Event Description

Product analysis for the generator m103 was completed and approved on (b)(6) 2015: in the product analysis 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. However, the battery, 2. 763 volts as measured during the final electrical test, shows an ifi=yes condition. There was no programming history available for this generator. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

 
Event Description

The patient's generator was replaced on (b)(6) 2015 due to prophylactic, ifi-yes. The device was received for analysis on 1/21/2015. Analysis is currently underway but has not been completed to date.

 
Event Description

It was reported that the vns patient was scheduled for surgery due to painful stimulation in the neck. The physician believed that replacement of the generator would resolve the patient¿s painful stimulation. The patient¿s device was tested and showed normal device function. 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 Key4397002
Report Number1644487-2015-03567
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 12/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date01/31/2015
Device MODEL Number103
Device LOT Number3546
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/30/2013
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: 01/08/2015 Patient Sequence Number: 1
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