MAUDE Adverse Event Report: RIGHT VENTRICULAR LEAD

Model Number 407652

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 06/28/2017

Event Type  No Answer Provided  

Event Description

Patient underwent pacemaker placement on (b)(6) 2017.On (b)(6) 2017, patient coded and expired.Autopsy results are pending and vendor for the pacemaker is currently interrogating the machine.At this time, there is no conclusive reason attributing the patient's death to the pacemaker.However, as a cautionary measure, this report is being submitted.Pacemaker: medtronic advisa mri dr ipg, model no.A2dr01, right atrial lead: model 407605, serial # (b)(4), right ventricular lead: model # 407652, serial # (b)(4).

• Brand Name: RIGHT VENTRICULAR LEAD
• Type of Device: RIGHT VENTRICULAR LEAD
• MDR Report Key: 6696568
• MDR Text Key: 79650652
• Report Number: MW5070847
• Device Sequence Number: 3
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 407652
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR