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

Model Number PM3542

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

Related manufacturer report number: 2017865-2019-05576.It was reported that there was a loss of sensing and an increase in pacing threshold on the right atrial (ra) lead.During the ra lead repositioning procedure, the ra lead could not be unscrewed from the header of the device.The ra lead was cut and the device was explanted and replaced.The distal portion of the ra lead was capped and remained implanted.The patient was stable with no adverse consequences reported.

Manufacturer Narrative

The reported device was returned for evaluation.The analysis revealed that the atrial setscrew was firmly stuck in the connector block and required destructive methods to separate it from the device connector.Analysis was performed using a scanning electron microscope and confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrew to get stuck.When the setscrew was tightened on the lead during the implant procedure the epoxy in the threads caused in the setscrew to be locked in place which prevented removal of the lead.A manufacturing anomaly may have occurred that left or caused the epoxy to be in the connector block threads.As a result of these findings, abbott is performing further investigation.Electrical testing was performed and revealed no anomalies.The battery voltage is above elective replacement indicator (eri) near beginning of life (bol).

• Brand Name: QUADRA ALLURE 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8520760
• MDR Text Key: 142337517
• Report Number: 2017865-2019-05575
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: A000070336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• 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