MAUDE Adverse Event Report: MPRI ATTAIN ABILITY MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number	419688
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: w1dr01 ipg; 5076-45 lead implanted: (b)(6) 2025 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 a loss of capture and oversensing was observed on both the right ventricular (rv) lead and right atrial (ra) lead.It was noted that the coronary sinus lead was in the right ventricular port of the implantable pulse generator (ipg).It was also noted that the patient heart rate was falling below the programmed lower rate limit.A right ventricular (rv) lead bipolar lead impedance warning was triggered due to high and undefined impedance measurements.It was noted that the rv lead exhibited high threshold measurements.The patient underwent a lead revision, and a leadless implantable pulse generator (ipg) was implanted and remains in use.The implantable pulse generator (ipg) system also remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 21936403
• Report Number: 2649622-2025-11670
• Device Sequence Number: 14750534
• Product Code: OJX
• UDI-Device Identifier: 00643169860032
• UDI-Public: 00643169860032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 419688
• Device Catalogue Number: 419688
• 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: 04/14/2025
• Initial Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 01/21/2025
• 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: 310C29 TISSUE VALVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female