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

Model Number	PM3542
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
During remote monitoring, episodes of far-field p-wave oversensing resulting in pacing inhibition were observed on the device.The pacemaker dependent patient experienced dizziness due to the pacing inhibition.The device was reprogrammed to resolve the event.The patient was in stable condition.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: 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: 15934020
• Report Number: 2017865-2022-48021
• Device Sequence Number: 12402893
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: A000065730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown