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

Model Number 106

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Positioning Problem (3009)

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

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during implant surgery the surgeon was experiencing difficulties getting the generator to properly detect the heartbeat.A pre-surgical evaluation was performed which indicated that the sensitivity setting should be set to 1 with the generator near the axillary position and approximately 5+ inches from the neck site.It was also noted during the pre-surgical evaluation that the patient's hr was 72 bpm.Initially the lead and generator were connected and the diagnostic results were within acceptable limits.However when the sensitivity level was set between 1-4 the heartbeat detection resulted with an error message, "????".The "????" error message indicates a loss of or no communication.A company representative then aided in troubleshooting attempts.The sensitivity level was then increased in 5 and the heartbeat detection measured heartbeats ranging from 197-212 bpm.It was confirmed that the programming system was functioning appropriately and the data receive light was flashing with the heart rate.Then the surgeon irrigated the nerve and set the sensitivity settings to 1.After this the heartbeat detection was correct with 71-73 bpm however it started to climb to 143-146bpm and eventually resulted in an error message "????".The surgeon made multiple attempts to adjust the sensitivity setting however each time the heartbeats detected would increase and eventually present with the "????" error message.It was noted that the patient was overweight and there was concern that this could be contributing to the heartbeat detection issues.However since a pre-surgical evaluation was completed this appears unlikely.Due to the heartbeat detection issues the surgeon decided to implant another generator.The suspect generator has been received and is pending product analysis.The manufacturing records of the suspect generator were reviewed and they indicated that the generator passed quality control inspection.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis on the generator found that it could be successfully interrogated and diagnostic testing was performed.The battery voltage was measured after the can was opened and the voltage was 2.975v.The generator performed according to functional specifications during product analysis however it was noted that the sense amplifier appeared to be too sensitive during testing.While there is not a lower limit for the minimum detected amplitude during testing, the results were noted to be lower than expected.Additionally, these values deviated significantly from those detected during initial manufacturing test.The internal data on the generator showed that the last recorded background heart rate was 95 bpm.These findings support the possibility that the generator was oversensing heart rate in the field based on these low amplitudes however the root cause of the oversensing could not be determined based on these results.Upon further review of the manufacturing records it was noted that while the generator passed r-wave configuration testing at all five gain settings for amplifier b, the recorded minimum sensing values were near the maximum allowed; particularly for setting #1.It was also noted that the generator initially failed final electrical test during manufacture when the generator became detached from the fixture during the test.The device was placed back on the fixture and retested where it passed final electrical testing.It was noted however that heartbeat verification was not performed again after the device became detached from the test fixture.This was based on the device previously passing heartbeat verification.

Event Description

Additional testing was completed on the generator.The generator's printed circuit board assembly was modified in order to be connected to the testing equipment.During testing gain settings #2 and #5 were out of specification for being oversensitive while gain settings #1 and #3 were under sensitive.It was noted that during the initial testing previously reported, all settings were overly sensitive.The generator was then tested again using the tests methods from initial product analysis testing.During this test only gain settings #1 and #3 did not meet specification due to undersensing.The results from the initial product analysis were not duplicated.The reason for the variation in results between testing is unknown.However a few potential causes were determined.Firstly, the battery was not removed until after the initial product analysis testing.It is possible that the generator was previously latched in to an unstable condition which cleared itself after a power cycle.Secondly, the printed circuit board assembly had several wires soldered onto it during the testing.It is possible that the mechanical handling and/or thermal cycling may have contributed to the generator's performance in subsequent testing.The cause of the oversensing that was initially observed could not be determined since the original behavior was not repeated in subsequent testing.

• 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: 6021258
• MDR Text Key: 57313749
• Report Number: 1644487-2016-02337
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: 106
• Device Lot Number: 203684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR