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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluated: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

 
Event Description

It was reported that the patient was complaining of pain around the vns in the chest and left shoulder. The pain occurred when the left chest area was touched. The patient was referred to a surgeon for further evaluation, including a ct of the left chest, an emg, and x-rays of the ribs without a possible cause for pain shown. There was no infection or any problems seen in the left chest. The patient was subsequently referred for explant surgery with relation to the tenderness over the left armpit and vns chest site. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.

 
Event Description

Further information was received from both the patient¿s treating neurologist and surgeon that showed the surgery was not to preclude a serious injury. The patient¿s generator was subsequently explanted in surgery. No additional pertinent information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key6653715
Report Number1644487-2017-04018
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/06/2017
Device MODEL Number105
Device LOT Number4293
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/20/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/31/2015
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: 06/20/2017 Patient Sequence Number: 1
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