MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE CADENCE; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number	22550A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the gel is detached from the electrode.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDI-TRACE CADENCE
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• MDR Report Key: 7736844
• Report Number: 1219103-2018-00014
• Device Sequence Number: 19095215
• Product Code: DRO
• UDI-Device Identifier: 10884527022304
• UDI-Public: 10884527022304
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: Health Professional
• Device Expiration Date: 06/13/2019
• Device Model Number: 22550A
• Device Catalogue Number: 22550A
• Device Lot Number: 718024X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1