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

Model Number 383069

Device Problems Under-Sensing (1661); Device Dislodged or Dislocated (2923)

Patient Problems Stroke/CVA (1770); Chest Pain (1776); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Pneumothorax (2012); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Heart Block (4444)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.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/75 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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: result of the physiologic pacing registry, an international multicenter prospective observational study of conduction system pacing.Heart rhythm.2023; 20:1617¿1625.Doi: 10.1016/j.Hrthm.2023.06.006.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 conduction system pacing (csp), including both left bundle branch area pacing (lbbap) and his-bundle pacing (hbp).The authors described one patient death; however, the cause of death was unknown, and it was deemed unclear if it was related to the procedure or device.There were patients who experienced adverse events related to the implant procedure or the csp lead which included infection, pneumothorax, cardiac tamponade, excessive bleeding, exit block, phrenic nerve stimulation, ventricular fibrillation (vf), chest pain, and stroke.There were hbp leads which exhibited undersensing and dislodgement and right atrial (ra) leads which also dislodged.The leads were either repositioned or replaced.The status of the leads is unknown.No additional adverse patient effects or product performance issues 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: 19005358
• MDR Text Key: 338932218
• Report Number: 2182208-2024-01395
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/03/2024
• 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: COMPETITOR ICD AND LEADS
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White