MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Arrhythmia (1721); Vomiting (2144)

Event Date 06/04/2019

Event Type  Injury  

Event Description

After implant surgery, the patient experienced four episodes of bradycardia and was non-responsive while in surgery recovery.It was noted that the patient was roused with a sternal rub and would then vomit.The device was programmed off after being programmed to 0.25 ma at time of surgery and there were no further episodes.The nurse present with the patient did not believe that the episodes were occurring with stimulation.The patient was taken to the intensive care unit and no further episodes occurred.The patient was then programmed back to 0.25 ma and has had no further side effects since then.The practitioners at the clinic noted that the events were believed to be related to anesthesia.Lead impedance was noted to be ok after implant.No other relevant information has been received to date.

Event Description

Further information was received from the physician¿s office.Per the physician, the patient did not have prior history of cardiac events and no family history of cardiac events.It was noted that the patient experienced bradycardia.Heart rate prior to event was in the 80s beat per minute and during the event was in 30s beats per minute.Blood pressure prior to the event was 126/98 to 112/75 during event.The event was reported to occur post-operative on date of implant.It was noted that the patient experienced nausea and vomiting.There was no medication change prior to the event.The event did not occur while performing diagnostics or with on time or a change in settings.The physician assessed the bradycardia to be not related to vns stimulation and not related to an vns exacerbation of bradycardia.Patient was administrated iv fluid and icu monitoring for event.An ecg received indicated that a sinus rhythm was diagnosed.It was noted that the arrhythmia event has not recurred.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8748532
• MDR Text Key: 149650081
• Report Number: 1644487-2019-01248
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2021
• Device Model Number: 1000
• Device Lot Number: 6176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2019
• 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): Hospitalization
• Patient Age: 18 YR