MAUDE Adverse Event Report: ABBOTT ALLURE CRT-P; NO MATCH

Model Number	PM3120
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Codes	Arrhythmia (1721); Syncope/Fainting (4411)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was not pacing and could not be interrogated.The patient had syncope and bradycardia; resuscitation was performed and the patient was hospitalized.Premature battery depletion was suspected on the device.The device was explanted and replaced to resolve the event.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The reported events of premature discharge of battery and no output were confirmed.The reported event of inability to interrogate was not confirmed.The device was received at end of service battery level.Device image analysis and functional device testing show sudden drop in voltage and elevated current.Visual inspection of the header attachment area detected an anomaly between the epoxy header and titanium case.The device was cut open to enable further testing and the battery was found depleted.Feedthrough leak test was performed, indicating a device hermeticity breach.This is consistent with feed through damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.Hybrid circuitry was tested by connecting to an external power source.Test results indicated elevated current drain, consistent with moisture damage, resulting in the reported event.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.

• Brand Name: ALLURE CRT-P
• Common Device Name: NO MATCH
• 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: 18904953
• Report Number: 2017865-2024-35015
• Device Sequence Number: 9136165
• Product Code: NIK
• UDI-Device Identifier: 05414734507882
• UDI-Public: 05414734507882
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/06/2024

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: 09/30/2018
• Device Model Number: PM3120
• Device Lot Number: A000038132
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 04/22/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/05/2024; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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