InjuryDRR

PRUKA CARDIOLAB

Received Sep 15, 2000 · Event occurred Sep 6, 2000

Report MW1019932 · MDR key 296515

Device

Generic name

Amplifier

Manufacturer

Ge/marquette

Model number

CLAB AMPLIFIER

Catalog number

Lot number

Product problems

Pacing Problem
Replace

Patient

69 YR

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

AMPLIFIER PACING CHANNEL FAILED DURING IMPLANTATION OF DUAL CHAMBER PACEMAKER NECESSITATING BYPASSING AMPLIFIER AND USING DIRECT STIMULATION. RPTR WAS USING A LOANER AMPLIFIER BECAUSE THEY HAD SEVERAL PROBLEMS WITH THIS PRODUCT AND HOSP'S AMPLIFIER WAS BEING FIXED. PT WAS NOT INJURED BECAUSE OF VERY QUICK ACTION OF MD/TECHNICIAN BUT THE POTENTIAL FOR PT INJURY/DEATH WAS PRESENT.