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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 04/04/2013
Event Type  Injury  
Event Description

On (b)(6) 2013, the patient reported that he was experiencing pain. Clinic notes dated (b)(6) 2013 were later received which state that the patient's seizures have never been controlled with his longest seizure free interval being two days. It was stated that the patient has several seizures per day, and that the vns worked well after it was implanted on (b)(6) 2012, until the patient had a lumber fusion in (b)(6). The notes state that as far as the patient is aware, the device was not turned off during the surgery. The patient states that his "vns is malfunctioning" as it cuts off his breath and he can feel it ¿run up (his) neck¿. It was stated that ¿when it fires, he feels like he has a frog in his throat¿. Additionally, it was stated that "it was 10 am before the vns ever went off" that morning per the patient. The notes state that when the device was placed, it helped reduce the seizure frequency from 15 - 20 per week to 10 per week as an estimate. The patient had 4 seizures the day before and two seizures so far that day per the notes. According to the clinic notes, the patient was involved in a car accident on (b)(6). The patient already had low back pain, but now there is a lot of pressure in his low back that was not there before and his back is sore. The patient has some joint pain and stiffness, and the notes state that he has a history of syncope additionally, the clinic notes state that the patient has a history of syncope and his generator will be replaced. The patient was prescribed keppra due to an increase in seizure frequency. The assessment/ plan portion of the clinic notes state "vagal nerve stimulator with malfunctioning generator". The patient has been referred to get the generator replaced. Attempts have been made for additional information; however, they have been unsuccessful. The patient was scheduled for surgery on (b)(6) 2013; however, he did not show up for this surgery. No new surgery date has been scheduled. No additional information has been provided.

 
Event Description

On (b)(4) 2013 it was reported that the patient was scheduled for surgery the next day. The surgery took place on (b)(6) 2013. The explanted generator has not been returned for product analysis to date. Also, it was reported that the patient¿s settings were programmed lower (output current and magnet pulse width) on (b)(6) 2013 which made the patient more comfortable.

 
Event Description

An implant card was received indicating the explant was due to painful and erratic stimulation. The generator was replaced and lead impedance was ok with impedance value 3108 ohms.

 
Event Description

It was reported that the explanting facility does not return explanted products.

 
Manufacturer Narrative

Inadvertently did not include the following on the initial report, "also, it was reported that the patient¿s settings were programmed lower (output current and magnet pulse width) on (b)(6) 2013 which made the patient more comfortable. ".

 
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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 Key3118959
Report Number1644487-2013-01414
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/19/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2013
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 Number3303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/30/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2012
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: 05/19/2013 Patient Sequence Number: 1
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