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

Model Number	419678
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
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 reported that the right ventricular (rv) his bundle lead no sensing in bipolar configuration.No capture was noted on the left ventricular (lv) lead lead.The rv lead was reprogrammed, explanted and replaced.The lv lead was reprogrammed and remains in use.No 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; vallalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; vallalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19030313
• Report Number: 2649622-2024-08984
• Device Sequence Number: 8035790
• Product Code: OJX
• UDI-Device Identifier: 00643169860025
• UDI-Public: 00643169860025
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/09/2021
• 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: 03/07/2024
• Initial Report FDA Received Date: 04/03/2024
• Date Device Manufactured: 06/28/2019
• 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: W1TR03 CRTP, 5076-45 LEAD, 383069 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male