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

Model Number 106

Device Problems Use of Incorrect Control/Treatment Settings (1126); Premature End-of-Life Indicator (1480); Failure to Sense (1559); Programming Issue (3014)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

During a generator replacement surgery on (b)(6) 2015, a m-106 generator was implanted and secured in the pocket by suture.A pre-surgical evaluation was not performed.The generator was interrogated and system diagnostics were performed showing impedance within normal range.The heartbeat detection was however unsuccessful.The heartbeat detection was turned on and setting 1 was programmed.At sensitivity setting 1, "*****" followed by "?????" was received.At sensitivity setting 2, "*****" followed by a very high heart rate around 140-160 bpm was received.The patient's accurate heart rate at this time ranged from 90 to 99 bpm.Troubleshooting was attempted by reducing electromagnetic interferences, confirming proper nerve irrigation, confirming the wand's functionality during the testing and confirming that all output currents are off.The device was left implanted at the end of the surgery.During the post-op, heartbeat testing was performed again and an accurate heart rate was received for 10-14 seconds at setting 1.A pre-surgical evaluation was then performed while patient was in prone position and left sided position.The patient's heart rate could not be obtained at setting 1 when the heartbeat testing was attempted.Troubleshooting was performed again.It was confirmed that the output currents were all programmed to 0.0ma.The tablet was not plugged into the wall.The wand battery was tested and the power light stayed on 25 seconds.At sensitivity setting to 2, a heart rate of 152 bpm was received.It displayed for a few seconds before "????" appeared.At sensitivity 1, a heart rate of 96bpm was received, which was a match for the patient's actual heart rate, but the display only lasted 3 seconds before "????" appeared.At this time, the tachycardia detection was left on but the auto-stimulation was programmed to 0.0 ma.On (b)(6) 2015, patient was scheduled for a follow up appointment.However patient experienced a seizure and was admitted to the er.Patient was treated and was slowly getting back to baseline.Once patient's condition was determined to be stabilized, the heartbeat testing was initiated as a part of the field action.Patient's normal and magnet mode stimulation was turned on prior to this visit.System diagnostics were within normal limits with 2054 ohms.The device appeared to be detecting the heartbeat as 23 detections were recorded to have occurred in the past 15 days since the previous office visit.The patient's heart rate was verified to be detected by the generator at a sensitivity setting of 1.Programming history is available from date of implant, (b)(6) 2015.Two system diagnostic tests were performed on (b)(6) 2015 and both show normal impedance results of 2568 and 2410 ohms.The battery indicator is ifi - no.On the date of implant, all output currents remained programmed off during the heartbeat testing and the normal and magnet output current were turned on (autostim - off).Tachycardia detection was programmed on, and sensitivity levels 1-3 were attempted.The device ultimately remained at sensitivity setting 3, with td on and autostim output current off on (b)(6) 2015.On (b)(6) 2015, two system diagnostic tests were performed on (b)(6) 2015 and both show normal impedance results of 2054 and 2038 ohms.The battery indicator is ifi - no.The normal and magnet output current were turned on but the autostim output current was off initially.Tachycardia detection was programmed on, and sensitivity levels 1 and 3 were programmed.At the end of the visit, the device was programmed to heartbeat sensitivity setting 1, with td on and all output currents on.

Event Description

Patient's generator battery was reported to be needing replacement despite being implanted only for 1.5 years.Patient's mom was very disappointed to hear that patient will need to have it replaced so soon.Patient will be referred for replacement.Patient's output current was increased to 2.75 ma, the magnet to 3.25 ma, and the autostim to 3.0 ma.The on time is 30 seconds and off time 1.1 min.Patient was referred for generator replacement and underwent replacement.The explanted generator has not been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The suspect generator was received.The reported allegations of undersensing, delayed/intermittent heartbeat verification, and premature discharge of battery were duplicated in the product analysis lab.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications with the exception of all five ¿clinical sense setting¿ test parameters.In addition, long sense delays (13.8 to 28.4 seconds) and sensing drops out conditions were observed on the bench oscilloscope during the r-wave configuration final test.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications with the exception of the expected low battery voltage of 2.579 volts (an ifi condition).With the battery removed, the printed circuit board assembly (pcba) was subjected to a postburn electrical test.Results show that the pcba failed several electrical tests: r2 verification, supply current 2ma/normal, supply current off, supply current off sense, and trim diagoncurrent.Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba.After the trimmed edge of the pcba was cleaned, a postburn electrical test was performed and the pcba passed the electrical tests that it previously failed.The pulse generator was re-assembled (with the original components) to the final configuration and subjected to manual sense testing at the pa bench.The pulse generator performed according to functional specifications.No long sense delays or sense drops out conditions were observed on the bench oscilloscope during the r-wave test.The contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current and sensing conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegations of undersensing delayed/intermittent heartbeat verification and premature discharge of battery.

• 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: 5225107
• MDR Text Key: 31700325
• Report Number: 1644487-2015-06344
• 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: Initial,Followup,Followup
• Report Date: 08/12/2017

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: Lay User/Patient
• Device Expiration Date: 07/13/2017
• Device Model Number: 106
• Device Lot Number: 203424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: 06/16/2017; 07/19/2017
• Supplement Dates FDA Received: 07/11/2017; 08/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2015-002-C
• Patient Sequence Number: 1
• Patient Age: 8 YR