MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

It was reported that the patient was scheduled for a generator replacement surgery due to battery depletion.Diagnostics was performed on the replacement generator while still in the packaging and the diagnostics were within normal limits.However, upon connecting the replacement generator to the implanted vns lead, high impedance was observed and the vns generator battery was at vbat < eos.The high impedance was reported in mfg.Report #1644487-2018-00804.The diagnostics also indicated that a high output current status was observed, which is reported in this mfg.Report.The surgeon stated that he may have touched the metal part of the torque screwdriver.The company representative stated that electrocautery was present in the field when the new generator was being implanted.A backup generator was implanted and a full vns replacement surgery occurred.The suspect generator was received by the manufacturer and is pending product analysis.No additional relevant information has been received to date.

Event Description

Generator product analysis was completed.The end of service message was verified in the product analysis, or pa, lab and was found to be associated with pulse disablement.Burn marks were noted on the generator case, indicating that the generator may have been exposed to electrocautery.The pulse disabled bit was able to be reset and subsequent testing was possible.Various electrical loads were attached to the generator and diagnostics were as expected in all instances.The electrical performance of the generator in the pa lab was used to conclude that no anomalies existed and that the pulse disabled condition was the result of exposure to electrocautery.The generator performed according to functional specifications.Other than the pulse disabled event, there were no performance or other adverse conditions found with the generator.Review of the export data revealed that there were no diagnostics performed on the day of the surgery until after the latch-up event.At that point, the vns generator battery was below the end of service, or eos, pulse disabled threshold.With the low battery, the normal lead impedance pulse or burst to determine what output current was achieved is not expected.The impedance value of 272,539 o, which is captured in mfg.Report #1644487-2018-00804, was a value from the last 24 hour measurement in which there would have been no lead attached.As for the output current status, the generator data still had values from the manufacturing test.These values are overwritten the first time a vns therapy burst is delivered.However, as there was no therapy burst, the values were never overwritten.Therefore, the programmer pulled 2.00 ma output current as delivered from the memory of the pulse generator.The programmed then interpreted the 2.00 ma while programmed to 0.00 ma as high output current.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: initial report inadvertently listed 'na' instead of (b)(4).

• Brand Name: PULSE GEN MODEL 104
• 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: 7524130
• MDR Text Key: 108611604
• Report Number: 1644487-2018-00803
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: 104
• Device Lot Number: 204306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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 Age: 50 YR