MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Output Problem (3005)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/01/2016

Event Type  malfunction  

Event Description

It was reported that a patient was not feeling magnet mode stimulation.The physician tried using several different magnets, but the patient did not feel magnet stimulation.The physician then checked the magnet activation count, and the count had not increased after interrogation.The last recorded swipe was from (b)(6) 2015, and the patient stated that she had swiped the magnet many times since then.The physician then increased the magnet mode output current, and he swiped the magnet again.The patient then felt stimulation, and the magnet swipe registered in the magnet activation count after re-interrogation.The physician then decreased the magnet mode again and swiped the magnet, but the magnet activation count did not increment.The physician then increased the magnet mode output current back to the higher output current that the patient could feel.Programming history was reviewed, and the impedance dcdc code was 2 in 2014.The impedance was dcdc code 0 on (b)(6) 2016.There was no indication that low impedance was present because no clinical symptoms had been reported.No further relevant information has been received to date.

Event Description

Programming history was reviewed on (b)(6) 2016.Data from (b)(6) 2016 showed that the output current was increased from 2.0ma to 2.25ma twice, as the physician previously reported.System diagnostics were performed with normal results.The magnet history showed that the device started at 137 magnet activations and ended at 142 magnet activations on (b)(6) 2016.This does show that the magnet activations did occur, but it cannot be determined when the activations occurred during the office visit in relation to the settings.The patient had generator replacement surgery on (b)(6) 2016, but the explanting facility does not return product to the manufacturer.Therefore, no analysis could be performed.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5546409
• MDR Text Key: 42500380
• Report Number: 1644487-2016-00704
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2016

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: MODEL 250
• Device Lot Number: 1075840
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/12/2016; 08/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR