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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 Problem Insufficient Information
Event Date 08/17/2015
Event Type  Injury  
Event Description

It was reported by a provider that a patient was experiencing pain at the generator site neck and the surgeon was planning to perform a surgical revision. The physician noted a nodule under the skin which did not cause pain upon palpation but the patient stated it was painful at other times. It was reported that the patient was having seizures whereas during a recent storm he only had one seizure. The patient's device normal mode and magnet mode output currents were decreased. Normal lead impedances were reported, however, neos status 3 days post-implant was yes but at subsequent device checks was no. Attempts for additional relevant information have been unsuccessful.

 
Event Description

Follow up with the provider indicated that the pain at the generator site was due to the presence of the generator. The neck pain was due to vns stimulation which was addressed by reducing device output parameters. The nodule was stated to be unrelated to the patient's vns system. It was stated that the patient only experienced increased seizures during storm activity and the overall seizure frequency was below the patient's pre-vns rate. The provider clarified that the battery status 3 days post-implant should have indicated no instead of yes. The provider stated that the surgical revision was for patient comfort purposes and to utilize the latest vns technology and not to preclude a serious injury. The provider stated that the lead would only be replaced if an issue was discovered with the lead intra-operatively as the most recent device check indicated normal lead impedance.

 
Event Description

Information was received indicating that the patient's pulse generator was successfully explanted and replaced as previously planned due to the patient report of pain. The patient's lead was not replaced. Lead impedance with the newly implanted generator was within normal limits. The explanted pulse generator was returned to the manufacturer and is currently undergoing product analysis.

 
Event Description

No performance or any other type of adverse conditions were found with the pulse generator and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The battery voltage battery was calculated to be 2. 967 volts and the battery shows an ifi=no condition. Measured battery voltage and consumed capacity parameters are as expected.

 
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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 Key5164366
Report Number1644487-2015-06154
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number103
Device LOT Number203081
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/11/2014
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: 10/21/2015 Patient Sequence Number: 1
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