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

Model Number PM3562

Device Problem Connection Problem (2900)

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

Event Date 06/22/2021

Event Type  malfunction  

Event Description

During the initial implant procedure, the left ventricular (lv) lead was unable to successfully connect to the header of the device.A replacement device was used, and the lv lead was successfully able to connect to the replacement device.The patient was in stable condition.

Manufacturer Narrative

As received, the device was at ddd mode above eri level.The device was then programed to nominal settings for the remainder of the analysis.The results of all electrical test performed, including mechanical stress testing and battery assessment indicate normal device characteristics.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.Analysis found no anomaly inserting and removing the leads from all the channels.The field complaint of failure to connect was not confirmed.

• 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
• MDR Report Key: 12093437
• MDR Text Key: 259183702
• Report Number: 2017865-2021-24452
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000121084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1