MalfunctionKRG
PROGRAMMER, PACEMAKER
Received Sep 28, 2023 · Event occurred Sep 12, 2023
Report 2124215-2023-53351 · MDR key 17835448
Device
Generic name
Programmer, Pacemaker
Manufacturer
Boston Scientific CorporationModel number
T175Catalog number
T175
Lot number
120893
Product problems
- High impedance
- High impedance
Patient
73 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD OF THIS PACEMAKER SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS, GREATER THAN 125 OHMS. UPON DEVICE INTERROGATION, THE IMPEDANCE WAS WITHIN NORMAL LIMITS AT 88 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. EVIDENCE SUGGESTS THAT THIS PACEMAKER REMAINS IN SERVICE.