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

Model Number 429888

Device Problems High impedance (1291); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) could not be programmed to an magnetic resonance imaging (mri) safe mode due to a high/undefined out of range (oor) left ventricular (lv) lead impedance measurement on the lv4 electrode.It was noted that the lv4 electrode is not currently in use.Additionally, it was noted that per an x-ray, the lv lead appeared to be pulled back.The lv lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: w4tr01 crt-p, implant (b)(6) 2018.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 PERFORMA MRI SURESCAN
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19147701
• MDR Text Key: 340750351
• Report Number: 2649622-2024-10925
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2020
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 08/21/2018
• 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: 5076-58 LEAD, 5076-52 LEAD
• Patient Age: 84 YR
• Patient Sex: Male