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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 02/07/2017
Event Type  Injury  
Event Description

A patient reported that while getting a head mri, the battery had not been turned off and she stated it got hot at the battery and at the attachment to the vagus nerve. The department was aware that she has a vns and was given her id (implant) card. The patient reported having passed out from pain. Follow-up by the company representative provided that the patient was last seen on (b)(6) 2017 and systems diagnostics were normal. The patient's generator was turned off. Additional relevant information has not been received to-date.

 
Event Description

X-ray images were received and reviewed. Based on the x-rays received, the cause for the painful stimulation could not be determined. There was no visual indication of damage to the generator or lead. However, the presence of an abrasion or a micro-fracture in the lead could not be ruled out.

 
Event Description

Follow-up from the physician has provided that the patient may have psych issues involved as well.

 
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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 Key6676919
Report Number1644487-2017-04065
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/15/2018
Device MODEL Number106
Device LOT Number5090
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/09/2016
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: 06/29/2017 Patient Sequence Number: 1
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