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

Model Number 106

Device Problems Image Display Error/Artifact (1304); Device Inoperable (1663)

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

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description

It was reported that during the patient's generator implant, the heart rate detection feature kept alternating between asterisks and question marks during testing of the device after it was placed in the patient, indicating interruptions in communication and an inability for the function to accurately detect heart rate.All sensitivity levels were reportedly tested several times, and the feature worked intermittently at a sensitivity of 5.It was verified that the generator was in the pocket.Tachycardia detection was on.System diagnostics were performed and were within normal limits.The generator was repositioned farther from the lead, and then closer to the heart, with sensitivity alterations and measurements being taken throughout.The surgeon completed the implant of the device in the position originally planned based on the pre-surgical screening.The patient was reported to have successfully completed the pre-or heart rate detection screening.The sales representative was present at the pre-surgical evaluation and indicated that there were no interruptions or complications.Pre-surgical evaluation was completed in all 7 positions, with a reported average amplitude of greater than 0.6mv.Results were not able to be analyzed as they were reportedly shredded after implant.Output current was programmed off while attempting to detect heart rate.The wand was reportedly held steady so there are no suspected communication issues according to the sales representative.The device history record for this generator was reviewed and showed that there were no non-conformances associated with this device prior to shipment.No additional relevant information has been obtained to date.

Event Description

Additional information was received that the patient's heartbeat was still unable to be detected at a follow up visit on (b)(6) 2015, though all heartbeat detection sensitivity settings were tested.The patient's diagnostics were reportedly normal.No additional relevant information has been obtained to date.

Event Description

Additional information was received that the vns heart rate detection feature for the patient is still no functioning properly.

Manufacturer Narrative

Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event.Action reported to fda; corrected data: 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 patient's implanted generator.Review of programming history shows data from the implant surgery as well as follow up visits on (b)(6) 2015.The programming data revealed that the generator was picking up heart rate.

• Brand Name: PLUSE 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: 4957686
• MDR Text Key: 23233465
• Report Number: 1644487-2015-05337
• 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
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: 54 YR