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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 03/21/2018

Event Type  Injury  

Event Description

It was reported that the patient had a prophylactic full revision surgery and experienced post-operative bradycardia that appeared to be a result of stimulation on times.The surgeon programmed the device off.There were no issues observed during the surgery or intraoperative bradycardia.The impedance during the surgery was within normal limits.No further relevant information has been received to date.

Event Description

Further details were received regarding the arrhythmia after vns surgery.The patient did not have a history of cardiac events or any other comorbidities listed.The medications provided to the patient during surgery were not available.The patient did request that she not have general anesthesia, but it was unknown if the patient had a previous reaction to general anesthesia in the past.The surgeon was not comfortable doing the surgery with only local anesthesia, so a full general was performed.The surgeon identified extensive scarring at the electrode site, which was attributed to the implant procedure, and the old electrodes were not removed from the nerve.The new electrodes were implanted above the old electrodes on the vagus nerve.The new device was set to the same settings as the previous generator, per the surgeon's instruction.The surgery was 1.5 hrs long, which was not considered to be a long surgery due to the full revision.The patient was fine during surgery when system diagnostics were performed.After surgery, the patient experienced asystole during stimulation along with significant coughing.Once the device was programmed off, the asystole and coughing did not occur again.The patient's device was programmed on by the neurologist.The patient did not experience any side effects at these settings, and titration was planned as normal.No further 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: 7445894
• MDR Text Key: 106003866
• Report Number: 1644487-2018-00618
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2019
• Device Model Number: 106
• Device Lot Number: 204340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR