MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

Device Problem Failure to Interrogate (1332)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

It was reported that the device was unable to communicate with radiofrequency (rf) telemetry.Abbott technical support alleged that the event was due to telemetry lockout.An attempt was made to reestablish rf telemetry by performing a software download, but it was not successful.The patient was in stable condition and will continue to be monitored.

Manufacturer Narrative

The reported event of no radiofrequency (rf) telemetry communication using the merlin transmitter was confirmed.Based on the provided information, it was determined that the device was in rf lockout, per design specification.The software that was redownloaded was an older version, which is why the lockout could not be resolved.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15204439
• MDR Text Key: 304925101
• Report Number: 2017865-2022-17320
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000146378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 12/03/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• 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