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

Model Number 106

Device Problems Failure to Sense (1559); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Positioning Problem (3009)

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the decision to implant with a m106 generator was made at the last minute, therefore none of the pre-surgical assessments were performed and the patient did not receive an ecg.During surgery, once the generator was implanted, there were communication errors therefore the generator was re-located.Once the generator was re-located, the communication errors resolved but then there was an issue with the heartbeat sensor failing to sense heartbeats due to what was considered to be the position of the generator.The heartbeat sensor was not enabled after the surgery.During the surgery, the output current was programmed off while attempting to detect the heart rate.In the verify heartbeat window, numbers popped up, but quickly disappeared.Then it flipped back and forth between question marks and asterisks.Levels 3, 4, and 5 were tried.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.A company representative reported that 1180 events were detected at the patient's follow-up appointment.They checked heart rate detection and lowered sensitivity.She was able to get appropriate heart rate temporarily but the number disappeared.The device seemed to be intermittently detecting a correct heart rate.At a subsequent follow-up appointment, it was reported that the heart rate detection while turned on, but not delivering therapy was accurate.The patient was then programmed to autostim at 0.625 at a 60% threshold.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

The previously submitted manufacturer report inadvertently did not include the recall reporting number assigned for the actions for the reported event.

Event Description

Programming history was reviewed for this device.Programming history is available from date of implant, (b)(6) 2015 to (b)(6) 2015.Two system diagnostic tests were performed on date of implant and both show normal impedance results of 1695 and 1567 ohms.The battery indicator was ifi no throughout this time.On the date of implant, all output currents remained programmed off during the heartbeat testing.Tachycardia detection was programmed on, and sensitivity levels 1, 3 and 5 were attempted.The device ultimately remained at sensitivity setting 5, with td on and autostim output current off on (b)(6) 2015.On (b)(6) 2015, the normal and magnet output current were turned on to 0.25ma and 0.5ma, respectively, but the autostim output current then programmed to 0.375ma.Tachycardia detection was programmed on, and sensitivity level of 3 and then 4 was programmed.The patient left the visit with the autostim output programmed off and was programmed to heartbeat sensitivity setting 5, with td off and normal mode and magnet output currents on.Foreground heart rate was measured between 98.2 and 118.6 bpm at sensitivity level of 5.On (b)(6) 2015, no programming changes were made to settings, but the heartbeat sensitivity was programmed from 5, then 2, to 1.The patient left the visit with the autostim output programmed off and was programmed to heartbeat sensitivity setting 1, with td on and normal mode and magnet output currents on.At sensitivity of 5, foreground heart rate was 98.2 bpm.On (b)(6) 2015, the normal and magnet output current were programmed up to 0.5ma and 0.75ma, respectively, and the autostim output current was off initially but was then programmed to 0.625ma.The patient left the visit with the autostim output programmed on and was programmed to heartbeat sensitivity setting 1, with td on and normal mode and magnet output currents on.At sensitivity of 1, foreground heart rate was 99.0 bpm.On (b)(6) 2015, no programming changes were made, including to the sensitivity settings or td setting.The patient left the visit with the autostim output programmed on and was programmed to heartbeat sensitivity setting 1, with td on and normal mode and magnet output currents on.At sensitivity of 1, foreground heart rate was measured at 94.9 and 99.5 bpm.On (b)(6) 2015, the normal and magnet output current were programmed up to 0.75ma and 1.0ma, respectively, and the autostim output current was programmed up to 0.875ma.The patient left the visit with the autostim output programmed on and was programmed to heartbeat sensitivity setting 2 with td on.At sensitivity of 2, foreground heart rate was measured at 106.4 and 118.6 bpm.No additional relevant information has been received to date.

Event Description

It was reported that the physician and patient are declining the offered troubleshooting to calibrate the heartbeat sensitivity setting for this patient's device as noted in the field safety notice.It was reported that the physician has been dosing the patient and the autostim has been working.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 5114839
• MDR Text Key: 27460547
• Report Number: 1644487-2015-05975
• 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: Other
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 09/02/2015

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 Expiration Date: 04/27/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/23/2015; 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z0280-2016
• Patient Sequence Number: 1
• Patient Age: 18 YR