InjuryLDF
SWAN GANZ
Received Aug 5, 2019 · Event occurred Jul 26, 2019
Report MW5088790 · MDR key 8865484
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Edwards Lifesciences LlcModel number
D97130FSLot number
62178567
Product problems
- Failure to Capture
Patient
78 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TEMPORARY PACEMAKER WAS INSERTED AND IT WAS NOT CAPTURING, SUSPECTED MALFUNCTION OF THE PACEMAKER LEAD. FDA SAFETY REPORT IDS# (B)(4).