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

Model Number	429688
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Twitching (2172)
Date of Event	08/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: w1tr01 crt-p 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 by the patient that they'd felt a pulsing sensation, almost like a twitch, in the lower part of their heart for a couple of years and it was increasing in frequency.The patient would feel it when sitting, standing, or lying down but not when moving around.Approximately two weeks later, the patient reported feeling muscle stimulation for the last few years.Two months later, the patient reported that the left ventricular (lv) lead was inactivated due to diaphragmatic stimulation.The lead remains in place.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY PLUS MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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: 23576553
• Report Number: 2649622-2025-32349
• Device Sequence Number: 9223205
• Product Code: OJX
• UDI-Device Identifier: 00613994719133
• UDI-Public: (01)00613994719133(17)170602
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 06/02/2017
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 06/30/2015
• 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: 407652 LEAD, 407645 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female