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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 Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2017
Event Type  Injury  
Event Description

A vns patient reported that she has a feeling of spiders going up her neck, and that the generator feels floppy in her chest. The device has been disabled, the patient has asked to have the device removed and has been referred to neurosurgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Event Description

Follow-up from the provider indicated the patient has some psych issues and claimed she had to balance the weight of the generator with her pack of cigarettes. However, the physician noted there was no migration of the device and was fine. The explant occurred for the patient comfort as she simply wanted it removed. It was also reported the patient believes the device was causing her psoriasis. Explant surgery occurred. The explanted devices were received by the manufacturer and analysis is underway, but has not been completed to-date.

 
Event Description

Follow-up to the physician provided that the patient has some psych issues and that the psoriasis is not related to the vns. The provider states the vns was working for the patient. Analysis was completed for the returned generator. Functionality of the generator to provide the programmed output currents was successfully verified. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Analysis was completed for the lead. The negative electrode was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device.

 
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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 Key6666114
Report Number1644487-2017-04038
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/27/2017
Device MODEL Number103
Device LOT Number203335
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/02/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2015
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: 06/25/2017 Patient Sequence Number: 1
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