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

Model Number	439878
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	11/25/2024
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 during a surgical procedure a lead integrity alert (lia) was triggered for high rate non-sustained episodes and sensing integrity counter (sic).There was oversensing and noise noted on the stored episodes.The patient received two inappropriate shocks from the cardiac resynchronization therapy defibrillator (crt-d) due to the lead noise.The patient also experienced phrenic nerve stimulation left ventricular (lv) lead post operatively.Follow up was conducted and noted that the cause of the inappropriate shocks was determined to be due to a total left shoulder arthroplasty surgery and were in response to the noise observed on the lead during the procedure.It was also noted that lv lead is programmed off.The crt-d remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA STRAIGHT 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: 21061326
• Report Number: 2649622-2025-00104
• Device Sequence Number: 8758366
• Product Code: OJX
• UDI-Device Identifier: 00643169002487
• UDI-Public: 00643169002487
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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 Expiration Date: 04/29/2017
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 06/17/2015
• 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: 359065 LEAD, 350973 LEAD, DTBA1Q1 CRT-D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 57 KG