MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ATTAIN ABILITY MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	419678
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: 5092-52 lead, implanted (b)(6) 2012.5076-45 lead, implanted (b)(6) 2012.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 or Problem Description
It was reported that the patient had significant bruising from the procedural table with ongoing discomfort at the cardiac resynchro nization therapy pacemaker (crt-p) site.It was further noted that the patient subsequently experienced left arm and left breast edema and at a left ventricular (lv) lead change out procedure, it was noted that a left extremity venography revealed there was significant venous stenosis/occlusion with extensive collaterals of the subclavian venous system with more at the subclavian axillary vein.The patient is a participant in a clinical study.The crt-p, right atrial (ra) lead, and right ventricular (rv) lead remain in use.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the new lv lead left bundle branch lead was related to the breast edema, bruising and discomfort.The lv lead left bundle branch lead remains in use.
Additional Manufacturer Narrative
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 or Problem Description
It was further reported that the patient underwent a left brachiocephalic and subclavian vein venoplasty.
Additional Manufacturer Narrative
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: ATTAIN ABILITY MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20622865
• Report Number: 2649622-2024-29803
• Device Sequence Number: 7353448
• Product Code: OJX
• UDI-Device Identifier: 00643169860025
• UDI-Public: (01)00643169860025(17)190914(21)PVI083019V
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/14/2019
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/29/2024; 12/08/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/26/2025
• Date Device Manufactured: 11/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: W1TR02 CRT-P.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White