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

Model Number	22770R
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1219103-2021-00340
• Device Sequence Number: 5337998
• Product Code: DRO
• UDI-Device Identifier: 20884527022400
• UDI-Public: 20884527022400
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 22770R
• Device Catalogue Number: 22770R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 09/14/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/01/2021; 10/18/2021
• Patient Sequence Number: 1