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

Model Number	PM3140
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, a rapid drop in battery longevity was observed.Premature battery depletion was suspected.Device replacement is anticipated.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information received indicated the reported battery depletion was believed to have been normal and a battery longevity overestimation occurred.The device was explanted and replaced to resolve the event.The patient was in stable condition.

• Brand Name: QUADRA ALLURE CRT-P
• 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: 16707631
• Report Number: 2017865-2023-17092
• Device Sequence Number: 3614915
• Product Code: NIK
• UDI-Device Identifier: 05414734507899
• UDI-Public: 05414734507899
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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: 11/30/2014
• Device Model Number: PM3140
• Device Catalogue Number: PM3140
• Device Lot Number: 4095455
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2013
• 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