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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/11/2017
Event Type  Injury  
Event Description

It was reported that a vns patient was observed overnight at the er complaining of painful stimulation. And continuous stimulation. The mom said she was feeling burning in her head. The physician requested the device to be turned off. Follow-up to the physician at the hospital provided that use of the magnet to disable the device was tried and did not resolve the issue. Additional relevant information has not been received to-date.

 
Event Description

Follow-up from the patient¿s caregiver on (b)(6) 2018 provided that the patient was in the er again due to painful stimulation.

 
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Brand NamePULSE GEN MODEL 106
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 Key7092861
Report Number1644487-2017-04946
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/10/2018
Device MODEL Number106
Device LOT Number5047
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2016
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: 12/07/2017 Patient Sequence Number: 1
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