Medtronic ICD
Received Jul 29, 2026 · Event occurred Jun 26, 2026
Report 2182208-2026-46441 · MDR key 50064672
Device
Generic name
Implantable Pacemaker Pulse-generator
Manufacturer
Medtronic, Inc.Model number
MDT-ICDCatalog number
MDT-ICD
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Unspecified Infection
Narrative
Description of Event or Problem
It was reported that approximately seven weeks post-Implantable Cardioverter Defibrillator (ICD) implant with an antibacterial absor bable envelope the patient developed an infection and the patient was hospitalized. The status of the device is unknown. 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.