MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Syncope (1610); Arrhythmia (1721); Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

Patient problem :(b)(4).

Event Description

It was reported that the patient's heart monitor was showing 69% bradycardia.It was also reported that the patient had dizziness-diminished eye focus, episodes of fainting, and felt like their throat was closing.The device was reported to be disabled and to monitor the patient.No additional relevant information has been received to date.

Event Description

Information was received form the physician's office that the patient did not have a prior history of cardiac events, but did have several pre-existing conditions.The patient did not experience any traumatic events or triggers prior to the arrhythmia.The event was reported to not have occurred during stimulation on times, following device diagnostics, or a settings change.The physician reported that the primary care physician stated the patient had a negative cardiac work-up.The physician reported that they did not believe the event was related to vns therapy stimulation or that vns exacerbated/co-currently contributed to the arrhythmia.The intervention taken (turning the device off) was not to preclude to a serious injury.Per the physician, the arrhythmia event has recurred.

• Brand Name: PULSE GEN MODEL 102
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7903445
• MDR Text Key: 121516540
• Report Number: 1644487-2018-01678
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2010
• Device Model Number: 102
• Device Lot Number: 2214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 12/09/2018
• Supplement Dates FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2008
• 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): Other