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

Model Number MODEL 3000

Device Problems Energy Output To Patient Tissue Incorrect (1209); Improper Device Output (2953)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 10/11/2017

Event Type  malfunction  

Event Description

It was reported that a patient who was recently implanted with a m106 device has complained of perceiving stimulation stronger than he had before he was programmed with the m3000 programming system.It was stated that the patient was reprogrammed back to intended settings with the m250 v.11.0 software programming system and stated that he felt fine again after they were adjusted.Data was reviewed from m3000 programmer which contained interrogation and programming events for the m106 from (b)(6) 2017, and from a v11 tablet containing interrogation and programming events for m106 from (b)(6) 2017.Office visit data stored within the generator's memory also indicated that the patient was also interrogated/programmed on (b)(6) 2017 but no corresponding events were found within the databases of the two tablets reviewed.On (b)(6) 2017, the device had programming adjustments to normal, magnet, and autostim output currents using the model 3000 tablet.Based on the available data, it appears that the normal mode and magnet mode currents were adjusted again on (b)(6) 2017 with a different v11 tablet while autostim was left the same.Having autostim output current programmed with a model 3000 while magnet current is programmed with a v11 tablet is a known condition that can lead to higher than intended output current and is one of the conditions for this programming issue.Data from (b)(6) 2017 indicates that the patient had logged 2 instances of a magnet overriding autostims, and if the magnet swipes on these events were > 40ms and < 300ms it would have resulted in the high current condition.As the patient's magnet current level was >= 0.75ma, no corresponding burst watchdog timeout was triggered.At the (b)(6) 2017 both magnet and autostim output currents were adjusted, after which the patient would no longer be susceptible to such events.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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7043147
• MDR Text Key: 93033674
• Report Number: 1644487-2017-04816
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• 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: Other
• Type of Report: Initial
• Report Date: 11/17/2017

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: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR