MAUDE Adverse Event Report: ETHICON ETHICON; ELECTRODE, PACEMAKER, TEMPORARY

Device Problems Break (1069); Pacing Problem (1439)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Ventricular wire (red connection) fell apart when rn lifted temporary pacemaker (tpm) from patient's chest.Attempt to connect patient to the pacing swan and the pacing swan would not pace.Soft chest compressions initiated until tpw could be reconnected.New pacing wire placed.

• Brand Name: ETHICON
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ETHICON; 1000 us highway 202 s.; raritan NJ 08869
• MDR Report Key: 15612088
• MDR Text Key: 301830833
• Report Number: 15612088
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27010 DA
• Patient Sex: Male