MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429888

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Sepsis (2067); Insufficient Information (4580)

Event Date 09/24/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 429888 lead, implanted: (b)(6) 2018; w4tr01 crt-p, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patients device system was explanted for an unknown reason.It was further noted that the patient is deceased and died the day of explant.The reason for explant and the cause of death were requested but not received.

Manufacturer Narrative

Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received, noted that the cause of death was provided as sepsis.It was noted, that the system was removed, due to bacteremia caused by staphylococcus aureus.The cause of the infection was avascular necrosis of the left hip.Unrelated to the device system.

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: ATTAIN PERFORMA MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 10901055
• MDR Text Key: 218149188
• Report Number: 2649622-2020-22890
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• Combination Product (y/n): Y
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2020
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4135 LEAD, 4136 LEAD; 4135 LEAD, 4136 LEAD.
• Patient Outcome(s): Death
• Patient Age: 90 YR