MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP CRT-P; Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Model Number PM3562

Device Problems Over-Sensing (1438); Pacing Problem (1439); No Pacing (3268)

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

Event Type  malfunction  

Manufacturer Narrative

The event date was estimated to have occurred between (b)(6) 2024 and (b)(6) 2024.Further information was requested but not received.

Event Description

It was reported that myopotential oversensing resulting in inappropriate automatic mode switch (ams) and pacing inhibition was noted on the device.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• 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: 19157348
• MDR Text Key: 340757990
• Report Number: 2017865-2024-39293
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM3562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: TENDRIL ST