MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA MRI XT DR SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDMB1D1
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	03/15/2024
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 the implantable cardioverter defibrillator (icd) detected multiple atrial arrhythmia episodes with rapid ventricular response (rvr).Therapy was initially; however, therapy was subsequently delivered for device detection of ventricular fibrillation (vf).Review of the episode data indicated the therapy may have been delivered during an atrial arrhythmia with rvr, specifically supraventricular tachycardia/atrial tachycardia-atrial fibrillation (svt/at-af), rather than true vf.It was further reported that the right ventricular (rv) and right atrial (ra) lead both exhibited high thresholds.The icd and leads remain in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5: corrected event description and typo/grammatical error h6 device codes (fdd/annex a): removed code a0713 as it does not apply to the reported event.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 implantable cardioverter defibrillator (icd) delivered therapy for device-detected ventricular fibrillation (vf).However, a review of the episode data and stored electrograms (egms) suggests that the therapy may have been inappropriately delivered during an ongoing atrial arrhythmia with rapid ventricular response (rvr)¿specifically supraventricular tachycardia/atrial tachycardia-atrial fibrillation (svt/at-af)¿rather than true vf.Therapy was initially withheld due to wavelet discrimination but was subsequently delivered after the device detected vf.Both the right ventricular (rv) and right atrial (ra) leads were noted to have high thresholds.The icd and leads remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA MRI XT DR SURESCAN
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23415681
• Report Number: 3004209178-2025-18441
• Device Sequence Number: 16019561
• Product Code: LWS
• UDI-Device Identifier: 00643169929197
• UDI-Public: (01)00643169929197(17)190128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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 Expiration Date: 01/28/2019
• Device Model Number: DDMB1D1
• Device Catalogue Number: DDMB1D1
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 08/03/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6945-58 LEAD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male