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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
Event Date 07/19/2012
Event Type  Injury  
Event Description

On (b)(6) 2015 it was reported that the patient¿s generator and a lead portion were explanted on (b)(6) 2013. The hospital reported that they do not return explanted devices, therefore the explanted products could not be returned for product analysis.

 
Event Description

The patient reported that she began to have pain behind the generator site after being implanted. The patient describes the pain as the muscles behind the generator becoming stiff and pullings when she turns her neck or move her shoulder. The patient's device was programmed off on (b)(6) 2013 to see if the pain was related to device stimulation; however, the patient indicated that the pain did not resolve and requested explant of the vns system. It was reported that the pain would occasionally occur with stimulation and that the physician directed that the device be programmed off. All device diagnostics were within normal limits. It was reported that the based on what the patient has told the physician he would attribute the pain to vns. Explant surgery is planned, but has not occurred to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3406219
Report Number1644487-2013-03147
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 09/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number3314
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2012
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: 10/11/2013 Patient Sequence Number: 1
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