MAUDE Adverse Event Report: REMINGTON MEDICAL, INC. EPICARDIAL PACING- DISPOSABLE SCREW DOWN EXTENSION CABLES; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number FL-601-97

Device Problems Disconnection (1171); Defective Component (2292); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

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.

• Brand Name: EPICARDIAL PACING- DISPOSABLE SCREW DOWN EXTENSION CABLES
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): REMINGTON MEDICAL, INC.; alpharetta GA 30005
• MDR Report Key: 16513294
• MDR Text Key: 311045564
• Report Number: MW5115599
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL-601-97
• Device Catalogue Number: FL-601-97
• Device Lot Number: 2222043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: White