MAUDE Adverse Event Report: MEDTRONIC IRELAND MEDTRONIC LEAD; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number UNK-COMP-LEAD

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 09/16/2021

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, approximately three days post implant of a leadless implantable pulse generator (ipg), the patient experienced an unwitnessed cardiac arrest, cardiopulmonary resuscitation was performed and the patient died.Post mortem computerized tomography (ct) out-ruled cardiac tamponade.Three days prior, during the implant procedure, the introducer sheath was difficult to insert, requiring enlargement of incision and inner cylinder dilatation.The leadless ipg delivery system exhibited stiffness on advancing to the right atrium.It was also reported that the leadless ipg was deployed eight times, using contrast, with unstable data, unstable thresholds, high thresholds and many premature ventricular contractions (pvcs) runs confirmed at various implantation positions.The temporary pacing lead, which had been inserted into the inferior vena cava (ivc), was then explanted.Additional information regarding the circumstances surrounding the patient's death has been requested and not yet received.

Event Description

It was further reported that there was no performance issue with the leadless ipg delivery system, the introducer or the temporary pacing lead.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC LEAD
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12602675
• MDR Text Key: 275843252
• Report Number: 9612164-2021-03876
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: UNK-COMP-LEAD
• Device Catalogue Number: UNK-COMP-LEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 70