MAUDE Adverse Event Report: COVIDIEN 1410Z KENDALL 1PR/PK 10PR/CA; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22770R

Device Problem Device Sensing Problem (2917)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported their patient was a man with a heart block and decreased bp.They were unable to get capture with trans cutaneous pacing.They tried multiple pads, multiple pad placements, and multiple zoll machines.There was no patient discomfort.

• Brand Name: 1410Z KENDALL 1PR/PK 10PR/CA
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque MA K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 12540252
• MDR Text Key: 273571369
• Report Number: 1219103-2021-00340
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022400
• UDI-Public: 20884527022400
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22770R
• Device Catalogue Number: 22770R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Patient Sequence Number: 1