MAUDE Adverse Event Report: COVIDIEN COVIDIEN DEFIB PADS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Lot Number 912034X

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Burn, Thermal (2530)

Event Date 05/21/2020

Event Type  Injury  

Event Description

Pt was undergoing a synchronized cardioversion.First attempt did not work.Burn marks were present at the patch site in the left axillary area.Patches removed.New patches applied and cardioversion was successful.

• Brand Name: COVIDIEN DEFIB PADS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10332231
• MDR Text Key: 200806048
• Report Number: MW5095750
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/14/2021
• Device Lot Number: 912034X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR