MAUDE Adverse Event Report: COVIDIEN FLEXON; TEMP CARDIAC PACING LEAD

Model Number 88862617-53

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2014

Event Type  Injury  

Event Description

Circular portion of pacing wire broke off in chest cavity.An x-ray was taken and confirmed that needle was located in chest.Provider searched for needle for approx 45 minutes but was unable to locate it.Since needle was in an area that would not produce any damage, decision made to let needle remain in pt.

• Brand Name: FLEXON
• Type of Device: TEMP CARDIAC PACING LEAD
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 3880369
• MDR Text Key: 4509915
• Report Number: MW5036651
• Device Sequence Number: 1
• Product Code: LDF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88862617-53
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR