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

Model Number 106

Device Problem Failure to Sense (1559)

Patient Problem No Code Available (3191)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that during initial implant surgery, the vns patient¿s device was unable to verify heartbeat detection except for a couple brief moments during the procedure.The pre-surgical assessment found the r-wave amplitude measurements ranged from 0.4-0.9 mv.It was noted that the r-wave amplitude was not measured with the patient in the prone position.The patient¿s device was unable to verify heartbeat detection at each heartbeat sensitivity level.The wand battery was replaced heartbeat detection was tested again but was unsuccessful.The device showed bpm - ????? or *****.When tested at sensitivity levels 3 and 5, the device was briefly able to detect heartbeat (bpm ¿ 74 and 190, respectively) but then showed bpm - ?????.The patient¿s generator was repositioned and the data transfer indicator of the programming wand was noted to be on when attempting to communicate with the device.There were no issues programming the device.The patient¿s device was tested and showed lead impedance within normal limits (impedance value ¿ 2035 ohms).The surgeon elected to complete the procedure and verify heartbeat detection at the follow-up appointment.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.The patient had an office visit on (b)(6) 2015 and the device still was unable to verify heartbeat detection except for two brief moments during testing.Heartbeat detection was tested using sensitivity 5 and the patient¿s heartbeat was measured as approximately 100 bpm for about a second then the screen showed bpm - ?????.The wand then powered down so the wand battery was checked and confirmed to be functioning normally.Heartbeat detection was tested again at sensitivity 5 and the same thing happened.The patient¿s device was tested and showed lead impedance within normal limits (impedance value ¿ 3326 ohms).Normal mode and magnet mode were programmed on and auto stimulation was left disabled.Tachycardia detection was left programmed on at heartbeat sensitivity level 5 and autostim threshold ¿ 40%.The patient returned to the office on 09/21/2015.The device tachycardia detection log was downloaded and showed approximately 1800 entries.The autostim threshold was subsequently increased from 40% to 70%.The neurologist elected not to test heartbeat detection during the office visit as he did not believe it would be successful, and planned to use to the tachycardia detection logs to manually calibrate the tachycardia detection device settings.No further information relevant to the event has been received to date.

Event Description

The patient was seen for a troubleshooting appointment.The generator was found to properly detect the heartrate with the appropriate heart beat detection feature.The physician programmed the heart beat detection feature on at the completion of the troubleshooting.

Event Description

Based on the information available to date, the cause for the reported intermittent heart rate detection may be related to the leakage paths on the side of the pcb created by removal of the tab from the pcb during the manufacturing process.

• 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: 5106011
• MDR Text Key: 26959506
• Report Number: 1644487-2015-05908
• 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: Patient Monitoring
• Type of Report: Followup,Followup,Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2017
• Device Model Number: 106
• Device Lot Number: 203460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• 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: 40 YR