MEDTRONIC LEAD
Received Jul 22, 2026 · Event occurred Feb 17, 2026
Report 2182208-2026-45179 · MDR key 25908607
Device
Generic name
Implantable Pacemaker Pulse-generator
Manufacturer
Medtronic, Inc.Model number
MDT-LEADCatalog number
MDT-LEAD
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Medical device site infection
Narrative
Additional Manufacturer Narrative
CONTINUATION OF D10: PRODUCT ID CMRM6133INT ((B)(6)); PRODUCT TYPE: 0001-ACCESSORY PRODUCT ID DDPA2D1 ((B)(6)); PRODUCT TYPE: 0235-ICD; IMPLANT DATE (B)(6) 2026; EXPLANT DATE (B)(6) 2026 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.
Description of Event or Problem
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, AN INFECTION WAS NOTED AROUND THE POCKET AREA. THE PATIENT WAS ADMITTED, CULTURES WERE TAKEN AND ANTIBIOTICS WERE ADMINISTERED. THE ICD SYSTEM WAS SUBSEQUENTLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..