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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 05/14/2014
Event Type  Injury  
Event Description

Additional information was received stating that the vns patient¿s seizures had improved but the patient¿s magnet appeared to making the seizures worse. The patient was also experiencing pain in her neck whenever the magnet was used. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

It was reported that the patient was still very weak. The device was not checked. It was later reported that the patient was doing better and walking and gaining strength. It was reported that the plan is for the patient to be seen in a few weeks to discuss proceeding forward with the revision. No surgical intervention was performed to date.

 
Event Description

It was reported that the lead revision had been cancelled. Additional information was later received that the patient was referred for generator replacement for an unrelated reason.

 
Event Description

Additional information was received that the patient is now going to have generator replacement and prophylactically replace the lead to prevent a potential revision in the future for patient comfort. No known surgical intervention has occurred to date.

 
Event Description

The explanted generator was received on 6/3/2015. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2015 but the lead was not replaced.

 
Event Description

It was reported that the vns patient was hospitalized due to a seizure she experienced when a system diagnostic test was performed on (b)(6) 2014. The patient had also been experiencing painful stimulation in her chest and neck as well as coughing and facial twitching with stimulation. The patient again experienced a seizure when the next system diagnostic test was performed on (b)(6) 2014 so the patient¿s neurologist stated that the system diagnostic tests were causing the seizures. The patient was given medication and taken to the er. It was noted that the patient¿s device settings were higher than those for system diagnostics and that system diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient¿s seizures were above pre-vns baseline levels. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The notes indicate that the patient had been experiencing an increase in seizures since she began using a hearing aid and that she had three seizures since her last office visit. The patient experienced a seizure the before the office visited which resulted in bruising in the arms. The patient stated that she was unable to tolerate magnet mode stimulation. The patient¿s device was tested during the office visit and the patient again experienced a seizure. Diagnostic results showed lead impedance within normal limits. The patient was sent to the er where the patient¿s device settings were lowered. X-rays were taken and were reported by the physician to be unremarkable. The physician recommended replacement surgery due to concerns with the patient¿s lead. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
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Brand NamePULSE GEN MODEL 102R
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 Key4052095
Report Number1644487-2014-02159
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number102R
Device LOT Number2064
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/03/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/03/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/30/2008
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: 09/02/2014 Patient Sequence Number: 1
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