MAUDE Adverse Event Report: MPRI SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number 383069

Device Problems Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Unstable Capture Threshold (3269)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Event Description

It was reported that approximately two weeks following implant, the right ventricular (rv) lead left bundle branch block lead and left ventricular (lv) lead exhibited suspected dislodgement.During a device interrogation, variable sensing and thresholds were observed on the rv lbbb lead and the lv lead.Phrenic nerve stimulation (pns) was present, which was noted to have not been present at implant.An x-ray was performed and it was noted both leads had moved since implant.The rv and lv leads were explanted and only the left bundle branch lead was replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: 693565 lead; implanted: (b)(6) 2024.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.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Returned product analysis was performed and no anomalies were found.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.Visual analysis of the lead indicated apparent explant damage.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.

• Brand Name: SELECTSECURE MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19048202
• MDR Text Key: 339430816
• Report Number: 2649622-2024-09304
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00763000740269
• UDI-Public: 00763000740269
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2024
• 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: DTPA2Q1 CRT-D, 429888 LEAD, 5076-52 LEAD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male