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

Model Number	DVMB1D4
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Tachycardia (2095); Shock from Patient Lead(s) (3162); Syncope/Fainting (4411)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that they experienced approximately three episodes of syncope, during which they fell to the ground.The patient stated that emergency medical technician (emt) personnel noted an abnormal rhythm and transported them to the emergency room (er).The patient recalled an additional episode three months and six months prior.The patient expressed concern that ¿something is not connecting¿ in their implantable cardioverter defibrillator (icd).The patient further reported feeling a shock-like sensation when touching doorknobs but was unsure if the icd delivered any therapy.The patient was unable to confirm whether the therapy was delivered appropriately.The icd remains in use.No further patient complications have been reported as a result of this event.
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.

• Brand Name: EVERA MRI XT VR 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: 22500412
• Report Number: 3004209178-2025-11945
• Device Sequence Number: 20637442
• Product Code: LWS
• UDI-Device Identifier: 00643169314153
• UDI-Public: (01)00643169314153(17)171114
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 11/14/2017
• Device Model Number: DVMB1D4
• Device Catalogue Number: DVMB1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 05/18/2016
• 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: 6935M62 LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male