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 05/04/2022

Event Type  malfunction  

Event Description

During device preparation, interrogation of the device was not possible.There was no patient involvement.

Manufacturer Narrative

The reported event unable to interrogate was confirmed.The device was received in backup condition.Analysis of the device image revealed that device went into backup mode due to reset error.The device was restored by reloading product code.Backup operation was reproduced at cold temperature, and this is consistent with an integrated circuit anomaly.Assessment of total projected longevity was performed, and the device was found to have appropriate remaining longevity.

• 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: 14461046
• MDR Text Key: 292381077
• Report Number: 2017865-2022-10597
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 05/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000112497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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