inforMED
MalfunctionDSA

EPICARDIAL PACING- DISPOSABLE SCREW DOWN EXTENSION CABLES

Received Mar 8, 2023 · Event occurred Feb 21, 2023

Report MW5115599 · MDR key 16513294

Device

Generic name

Cable, Transducer And Electrode, Patient, (including Connector)

Model number

FL-601-97

Catalog number

FL-601-97

Lot number

2222043

Product problems

  • Disconnection
  • Defective Component
  • Incomplete or Inadequate Connection

Patient

55 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT HAD A TEMPORARY PACEMAKER, AND DISLODGE THE CABLES FROM THE PACER BOX. WHEN THE CABLES WERE TESTED, THEY DID NOT CLICK INTO A LOCK POSITION DUE TO A DEFECT. THE CABLES WERE REPLACED. A 55 YEAR OLD MALE UNDERWENT DOUBLE VALVE AND CORONARY ARTERY BYPASS (B)(6) 2023. TWO TEMPORARY RIGHT VENTRICULAR PACER WIRES WERE IN PLACED, AND CONNECTED TO TEMPORARY PACER BOX AFTER SURGERY.