MAUDE Adverse Event Report: MEDTRONIC, INC. SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number 383069

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/17/2022

Event Type  Death  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/70 years old.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: clinical outcomes of permanent left bundle branch area pacing in patients with left bundle branch block and left ventricular ejection fraction greater than 35 vs.Less than or equal to 35%.Frontiers in cardiovascular medicine.2022; vol 9, article 838708.Doi: 10.3389/fcvm.2022.838708.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding clinical outcomes of permanent left bundle branch area pacing (lbbap).The authors described patient deaths; the causes of death included death from any cause or for progressive heart failure (hf).One patient with lvef lower than 25% was noted to have passed soon after left ventricular septal pacing (lvsp) due to ventricular fibrillation (vf).There is no allegation of lead-death relatedness indicated in the article; however, the lead-relatedness has been requested, but not yet received.There were patients who experienced pocket infections and underwent incision and drainage of the device pocket and patients who experienced heart failure hospitalizations.The status of the leads is unknown.No additional adverse patient effects were reported.

• Brand Name: SELECTSECURE MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18974181
• MDR Text Key: 338527204
• Report Number: 2182208-2024-01273
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 383069
• Device Catalogue Number: 383069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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
• Treatment: UNKNOWN COMPETITOR CIED
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male