MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Output Problem (3005)

Patient Problem Seizures (2063)

Event Date 05/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 from the physician that the patient was seen that day due to increase in seizures.At the patient's last appointment in (b)(6) the device was set to 2.0/20/250/21/1.1, mag 2.25/60/500, autostim 2.25/60/500, with the threshold at 40% and sensitivity to 1 then interrogated it to confirm programming.The physician stated that she interrogated the patient's device on (b)(6) 2016 and found that all output current settings (normal, magnet, and autostim) had been reset to 0ma and she stated there was a message that said "the device has gone into protective mode." she looked at the magnet history and the last magnet swipe recorded was on (b)(6) 2016, so she thinks this may have been when it happened, and patient has likely been without therapy since then.The physician turned the device back on, but at 1.5ma, 1.625 autostim, 1.75 magnet.She wanted autostim to be higher than normal mode, but didn't want the magnet to be a full 0.5 ma higher.All other settings had not been changed and were kept the same.

Event Description

The generator decoder was reviewed on (b)(6) 2016 and shows that on (b)(6) 2016 the patient came into the office at disabled settings when they were previously interrogated in (b)(6) at settings of 2/20/250/21/1.1/2.25/500/60 with autostim 2.25/500/60.Review of the decoder does show that the settings were disabled on (b)(6) 2016 due to a "burst watchdog timeout" the physician had called cts on (b)(6) 2016 and was instructed to program the magnet mode greater than autostim so the final settings on (b)(6) 2016 were 1.5/20/250/21/1.1/1.75/250/60 with autostim 1.625/250/60.The last recorded settings were from (b)(6) 2016 and show 1.75/30/250/21/1.1/2/250/60 autostim 1.875/250/60.

Event Description

It was reported by the mother of the patient that the device was explanted.The product has not been received to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 5806861
• MDR Text Key: 50729698
• Report Number: 1644487-2016-01633
• 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: Consumer,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/29/2024

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: 01/15/2018
• Device Model Number: 106
• Device Lot Number: 203698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/16/2016; 09/15/2016; 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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: 19 YR
• Patient Sex: Female