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

Model Number PM3562

Device Problem Pacemaker Found in Back-Up Mode (1440)

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

Event Date 05/07/2021

Event Type  malfunction  

Event Description

During an implant procedure, it was noted that the device was in backup vvi before it was implanted.The cause of the backup vvi is unknown.Another device was successfully implanted to resolve the event.The patient was stable.

Manufacturer Narrative

The device was returned due to being in backup mode.The device image indicated that a reset error had occurred and caused the device to revert to backup mode.The product code was downloaded, and analysis was performed.Backup operation was reproduced at cold temperature, consistent with an integrated circuit (ic) anomaly.Assessment of total projected longevity was performed, and the device was found to have appropriate longevity remaining.

• 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: 11863698
• MDR Text Key: 251954021
• Report Number: 2017865-2021-18681
• 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: 06/22/2021

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: 07/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000116443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1