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

Model Number	479878
Medical Device Problem Code	Extracardiac stimulation (1463)
Health Effect - Clinical Codes	Hiccups (1899); Device Overstimulation of Tissue (1991)
Date of Event	05/22/2026
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
The patient reported that "this thing is huge compared to my stj device" and also stated "this device was beating like a drum".The patient is not feeling the "bang" at home. the cardiac resynchronization therapy pacemaker (crt-p) remains in use.  no further patient complications have been reported as a result of this event.It was further reported postoperatively when the patient woke up they experienced phrenic nerve stimulation that felt like "hiccups", they were visible to the eye, and phrenic nerve stimulation was able to be felt on their chest.It was further reported that the patient felt like their heart was beating fast and their side was sore due to the crtp.The patient explained that the "device was beating like a drum" was different than the phrenic nerve stimulation.The left ventricular (lv) lead was reprogrammed.The patient reported not feeling the phrenic nerve stimulation following reprogramming.There was no performance issue with the crtp.The crtp and lv lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STABILITY QUAD 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: 25591989
• Report Number: 2649622-2026-18565
• Device Sequence Number: 5444990
• Product Code: OJX
• UDI-Device Identifier: 00643169860414
• UDI-Public: (01)00643169860414(17)280312
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 479878
• Device Catalogue Number: 479878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 06/23/2026
• Date Device Manufactured: 03/25/2026
• 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: W4TR01 CRTP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male