MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 7103; GENERATOR

Model Number 7103

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

Patient Problem No Code Available (3191)

Event Date 12/12/2020

Event Type  Injury  

Event Description

It was reported that a clinical study patient had a non-st elevated myocardial infarction possibly related to the vitaria implant.Event stop date noted to be (b)(6) 2020.Information received from the reconciliation report indication that the patient had a non-st elevation myocardial infarction it was noted to be possibly related to vitaria because it occurred shortly after vitaria implant.It was noted to be possibly related to vitaria stimulation and definitely related to vitaria system (other) because of "newly reduced [ejection fraction] 25 ->10%, increase in troponin." (which may mean that the events occurred since onset of stimulation).It was noted to be possibly related to worsening heart failure and not related to other study procedure.It was a serious adverse event and the patient was hospitalized due to the worsening heart failure/troponin elevation.The patient received a stent (left anterior descending artery), cardioversion and their heart failure medication was changed.Diagnostics are within normal limit.No further relevant information has been received to date.

Event Description

It was reported that the day of the event patient presented with pressure pain over the chest since that morning, with improvement with a change of position.A brief episode of dyspnea was noted in association with these events.Ecg on admission) revealed marked left axis deviation, atrial fibrillation, normal heart rate, right bundle branch block, and ventricular stimulation.The safety physician reviewing the relatedness of the event to the vitaria disagreed with this assessment that the event was possibly related to the vitaria and stated assessment that the event was that "the admission for the mi was ~ 2 1/2 weeks after the implant procedure so it seems unlikely related.The reduced ef may have been transient due to the myocardial infarction and ischemia.No further relevant ifnromation has been received to date.

Event Description

Information received that the study principle investigator reported that they thought that there was a temporal connection with titration, for vitaria system other causality.Information received that the event was not related to vitaria system (other) and that it had been noted to be definitely related in error.

Manufacturer Narrative

Device information manufacturing date, corrected data: the initial mdr inadvertently did not include the generator serial number, lot number, implant date, expiration date and manufacturing date.

• Brand Name: PULSE GEN MODEL 7103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11136055
• MDR Text Key: 225772142
• Report Number: 1644487-2021-00029
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2021

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: 03/23/2022
• Device Model Number: 7103
• Device Lot Number: 205282
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/21/2021; 02/24/2021; 05/07/2021
• Supplement Dates FDA Received: 02/15/2021; 02/24/2021; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR