PROGRAMMER, PACEMAKER
Received Feb 24, 2023 · Event occurred Feb 8, 2023
Report 2124215-2023-08856 · MDR key 16440822
Device
Generic name
Programmer, Pacemaker
Manufacturer
Boston Scientific CorporationModel number
T175Catalog number
T175
Lot number
130923
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR · Male
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT THIS DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS EXPLANTED.