MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number 3000

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Voluntary medical device correction (remedial action) was initiated by the manufacturer on 2/4/2020, and the physician was provided a notification letter with recommended actions.Internal reference number: (b)(4).

Event Description

It was reported that the patient's generator was observed to have current not delivered after being programmed off and back on for an mri.A different programming system was used and the error message was not observed.It was noted that the treatment decision was not change due to the low output current observed.Internal testing and data review identified that false low output current messages can occur when m3000 v1.6, software programs a m103-106 generator after a specific programming sequence occurs.When m3000 v1.6 tablets initiate a programming session with a m103-106 generator, where its output current is programmed off (0 ma), and then the output current is programmed back on to ma, a low output current message would be seen when an in-session interrogation is performed.This would persist upon multiple in-session interrogations and if diagnostics weren't performed during the session, show on the session report.Running system diagnostics or ending and restarting the session will confirm functionality of the device, and resolve the "output current low" error message.The low output current messages in these cases are false and do not impact generator function.Based on the reported programming sequence that occurred that day, it was consistent with the false low output current mechanism described above.Therefore, the patient's generator is expected to be able to deliver therapy as programmed.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10839544
• MDR Text Key: 216352394
• Report Number: 1644487-2020-01534
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• 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
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2018
• 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: 39 YR