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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 03/23/2015
Event Type  Injury  
Event Description

It was reported that the patient has had pain in the vns region of the neck since the first date of initial implant. Therefore, it was felt that since the patient was still complaining of pain with the replacement vns system, that the physician did not see any reason for it to remain implanted. It was felt to be removed more for patient comfort reasons.

 
Manufacturer Narrative

Describe event or problem: the initial report inadvertently did report this information.

 
Event Description

The patient had generator and lead replacement surgery on (b)(6) 2015 due to pain and painful stimulation. At that time, the physicians reported that the surgery was for patient comfort reasons and not to preclude a serious injury. The implant card reported that lead impedance was okay after replacement surgery. Additional information was later received that patient complained of pain after the surgery. Initially at post-op appointment on (b)(6) 2015, the notes recorded no post-operative complications and no patient complaints. The scars/incision sites were reported to be healed nicely. Later on (b)(6) 2015, the notes reported that the patient reported having continued problems with a burning sensation and a sensation of electricity around the vns site. The pain/discomfort did not improve after full replacement surgery. She could not tolerate this continued problem. The clinic notes from (b)(6) 2015 reported that the patient presented after full replacement complaining of pain in the area of the vagus nerve stimulator and neck. The patient reported that the pain was persistent if the device was not on. As a result, she wanted the device removed. The patient's device was programmed off due to the pain, and the physician assessed that it needs to be removed due to pain experienced even with the device off. The patient was referred for removal of the vns. The manufacturer¿s field clinical engineer attended the explant surgery on (b)(6) 2015. Explant of the generator and lead occurred on (b)(6) 2015, and the explanted devices were discarded. As a result, product analysis is unable to be performed.

 
Manufacturer Narrative

(b)(4).

 
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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 Key4760249
Report Number1644487-2015-04653
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/15/2016
Device MODEL Number103
Device LOT Number203154
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2014
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: 05/08/2015 Patient Sequence Number: 1
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