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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 01/07/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient has been sick since device was placed. The physician thought it was the medications and changed her medications. Patient stated that she was in the hospital for septic shock from (b)(6) and was in the hospital on (b)(6) 2016. Patient experiences shocking sensations despite holding the magnet over the device. The tape over the magnet is peeling her skin since she has had the magnet in place for 3 weeks and that when she changes the tape it peels her skin. Per the neurologist and primary care physician, patient has permanent ekg changes and electrical conductive problems w/ her heart that is related to the vns device. The patient had a chemical stress test and was in vtach. Patient was given medication to slow her heart rate. Patient would like tc to visit and turn off vns but tcs need physician's written consent to do so and patient has not yet seen their neurologist. Patient was seen by a different neurologist on (b)(6) 2016. Per the nurse at the office, the vns was not evaluated at that time and the device was believed to be off. Additional relevant information has not been received to date.

 
Event Description

Additional information was received that the patient underwent surgery to have vns generator removed on (b)(6) 2016. Per the surgeon, patient did not have a history of any heart issues or risk factors that makes them more susceptible to heart issues prior to vns implantation. The patient reported that the sepsis was not related to vns therapy. The explanted generator has not been received to date. No other relevant information was received.

 
Event Description

The explanted generator was returned to the manufacturer. Analysis is underway but has not been completed.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 106
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 Key5975296
Report Number1644487-2016-02185
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Type of Report Followup,Followup,Followup
Report Date 01/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/22/2017
Device MODEL Number106
Device LOT Number203585
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/02/2015
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: 09/23/2016 Patient Sequence Number: 1
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