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

Model Number	PM3542
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device could not be interrogated.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of wireless communication problem was not confirmed.Device image analysis indicated excessive high powered telemetry usage which caused device to temporarily disable rf telemetry to preserve battery power.The monthly current trend was normal, and voltage was in normal range of operation.Further electrical and mechanical analysis performed in nominal setting did not find any anomaly and device was able to be interrogated through rf telemetry.Longevity assessment was performed, and device was found to have appropriate remaining longevity.

• 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: 16857360
• Report Number: 2017865-2023-18994
• Device Sequence Number: 3365731
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: P000160804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown