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

Model Number PM3542

Device Problem Failure to Interrogate (1332)

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

Event Date 04/21/2023

Event Type  Injury  

Event Description

It was reported that the device could not be interrogated.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event of wireless communication problem was not confirmed.Device image analysis indicated excessive high powered telemetry usage which caused device to temporarily disable rf telemetry to preserve battery power.The monthly current trend was normal, and voltage was in normal range of operation.Further electrical and mechanical analysis performed in nominal setting did not find any anomaly and device was able to be interrogated through rf telemetry.Longevity assessment was performed, and device was found to have appropriate remaining longevity.

• Brand Name: QUADRA ALLURE MP
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16857360
• MDR Text Key: 314437578
• Report Number: 2017865-2023-18994
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: P000160804
• 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: 04/21/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2023
• 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
• Patient Outcome(s): Required Intervention