MAUDE Adverse Event Report: ABBOTT PROMOTE+ CRT-D W/SJ4 CONNECTOR; No Match

Model Number CD3211-36Q

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported that noise was observed on the device.The noise led to oversensing on the right ventricular (rv) lead and right atrial (ra) lead.Inappropriate automatic mode switch was also observed.The cause of the noise was suspected to be due to electromagnetic interference.Lead damage on the rv lead and ra lead was also suspected but not confirmed visually.No intervention was performed; the patient was stable and will continue to be monitored.There were no adverse consequences.Related manufacturer reference number: 2017865-2024-34130, 2017865-2024-34132.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• Type of Device: No Match
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18837765
• MDR Text Key: 336956092
• Report Number: 2017865-2024-34128
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503679
• UDI-Public: 05414734503679
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CD3211-36Q
• Device Lot Number: S000014389
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1