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

Model Number	MODEL 3000
Medical Device Problem Codes	Energy Output To Patient Tissue Incorrect (1209); Improper Device Output (2953)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7043147
• Report Number: 1644487-2017-04816
• Device Sequence Number: 16600261
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR