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

Model Number PM3242

Device Problems Incorrect Measurement (1383); Failure to Disconnect (2541); Interrogation Problem (4017)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that the device was implanted in 2013 but the exact implant date was unknown.

Event Description

It was reported that overestimation was observed on the device during follow-up.During subsequent follow-up, the device was found to have reached its elective replacement indicator (eri).Slow interrogation was observed on the device.The device was explanted and replaced to resolve the event.During explant, there was difficulty removing the right ventricular (rv) lead from the header of the device.The device was successfully explanted and replaced to resolve the event.The patient was stable following the procedure and there were no adverse consequences.

Manufacturer Narrative

The longevity estimation anomaly near elective replacement indicator (eri) was confirmed by reviewing the data in the session records and device image data.The longevity overestimation was determined to be due to an estimation inaccuracy in the programmer remaining longevity calculation.An enhancement request was also submitted by the software engineering team to resolve the issue in the future.The reported event of difficulty removing the right ventricular (rv) lead from the header was confirmed.Analysis found the returned device had the original header design with tighter tolerances for this design.Excess force and/manipulation maybe required to insert the leads into the connectors, and almost equal or greater forces would then be needed to remove the leads, which likely occurred in the field, during the replacement surgery.The reported event of no audible alert for end of service (eos) was confirmed.The device is not designed to have an audible eos patient notifier alert.

• Brand Name: ALLURE QUADRA RF 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: 13476527
• MDR Text Key: 285233992
• Report Number: 2017865-2022-02790
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/29/2022

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: 06/30/2015
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4395743
• 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: 01/24/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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