MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Depression (2361)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

It was reported by the patient that she felt that her depression was worsening.The patient was to follow-up with her physician in order to get the vns checked as she felt that the depression was a result of a low vns generator battery.Clinic notes were received by the manufacturer showing that the vns was pulse disabled, or programmed off due to the vbat being less than the end of service, or eos, threshold.The tablet data for the generator was received and reviewed by the manufacturer.The device was confirmed pulse disabled.The discrepancy between the diagaccum consumed value and the battery voltage on the date in the clinic notes provided is an indication that the battery was depleting faster than expected.It is unknown whether this is the result of an asic latch-up condition caused by exposure to electrocautery.A review of device history records revealed that the generator passed quality control inspection prior to distribution and was manufactured well before laser routing was utilized.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent vns generator replacement surgery due to battery depletion/pulse disablement.High impedance was observed during pre-op diagnostic testing.The surgeon did not replace the vns lead.The patient informed the surgeon that she was experiencing sporadic painful shocks.The high impedance was also seen on the newly implanted generator.The high impedance and painful shock events are reported in mfg.Report #1644487-2019-00022.The patient reported that she was very depressed.The explanted generator was received by the manufacturer and is pending product analysis.

Event Description

Generator product analysis was completed.The premature end of life, or eol, allegation was not verified in the product analysis, or pa, lab.The end of service warning message was verified in the pa lab and found to be associated with pulse disablement by the generator due to the generator remaining on post-explant.The last greater than 25% change in impedance was on the date of explant and the impedance went from 5,596 o to 15,596 o.The high impedance and the output current remaining on post-explant required a vboost compliance voltage exceeding the maximum compliance voltage capability.This is not considered a device failure, but an expected event due to the device remaining programmed on.A reset of the pulsedisabled bit allowed for subsequent testing.Proper functionality of the device was successfully verified in the pa lab.The septum was noted cored, eliminating the possibility of an unintended electrical current path through body fluids.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No variation in the output signal was observed and the generator provided the expected level of output current.Diagnostics were as expected.The generator performed according to functional specifications.Other than the noted vboost compliance voltage and pulsedisablement, there were no additional performance or other adverse conditions found with the generator.The high impedance and painful stimulation were reported in mfg.Report #mfg.Report #1644487-2019-00022.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8144303
• MDR Text Key: 129752169
• Report Number: 1644487-2018-02248
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/23/2015
• Device Model Number: 105
• Device Lot Number: 202808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 01/22/2019
• Supplement Dates FDA Received: 01/07/2019; 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR