MAUDE Adverse Event Report: ARROW TEMPORARY PACER; ELECTRODE, PACEMAKER, TEMPORARY

Device Problems Unable to Obtain Readings (1516); No Pacing (3268)

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

Event Type  malfunction  

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, the temporary pacer (arrow) was not capturing.Subsequently a permanent pacemaker was implanted with no adverse patient effects reported.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TEMPORARY PACER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ARROW
• MDR Report Key: 17533584
• MDR Text Key: 321156803
• Report Number: MW5140488
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1