MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES SWAN GANZ; ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Pacing Intermittently (1443)

Patient Problem Asystole (4442)

Event Type  Injury  

Event Description

Medtronic received information that one day post implant of a transcatheter bioprosthetic valve, the patient developed complete heart block.There was intermittent failure of the temporary pacing wire (edwards lifesciences swan ganz, serial number (b)(6), leading to short periods of asystole.The temporary pacing wire was repositioned.Subsequently a permanent pacemaker was implanted with no adverse patient effects reported.Pcr: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EDWARDS LIFESCIENCES SWAN GANZ
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 17524583
• MDR Text Key: 321061766
• Report Number: MW5131529
• 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: 06/03/2011

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