InjuryKRG
IMPLANTABLE DEVICE
Received Apr 16, 2024 · Event occurred Jan 1, 2011
Report 2124215-2024-23149 · MDR key 19122698
Device
Generic name
Implantable Device
Manufacturer
Boston Scientific CorporationModel number
A155Catalog number
A155
Lot number
112724
Product problems
- Defective Device
- Defective Device
Patient
59 YR · Male
- Bacterial Infection
- Bacterial Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE HAD EXHIBITED VEGETATION ON LEADS WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. A REVISION WAS PERFORMED AND THE DEVICE ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS NOT RETURNED FOR ANALYSIS.