MAUDE Adverse Event Report: ABBOTT IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5180
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device was explanted and replaced after reaching elective replacement indicator (eri) level.It is unknown whether or not the physiologist alleged a malfunction against the device.The patient was in stable condition.
Event or Problem Description
Additional information received indicated the device was explanted and replaced after reaching normal elective replacement indicator (eri) battery level.During the procedure, the physician alleged a complaint that the autocapture function was turned off and the device was programmed at a fixed output.
Additional Manufacturer Narrative
The device was received in backup mode which occurred post-explant, and with battery voltage at end of service level.Review of the device image indicated the device triggered a false elective replacement indicator (eri) alert consistent with auto-capture and high output condition.The device code was re-loaded, and the pacer was set to nominal conditions after replacing the battery.Electrical testing was performed under nominal condition and indicated normal functionality.An evaluation of the output indicated all parameters were within normal range of operation.Additionally, a longevity assessment was performed, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: IDENTITY ADX SR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14119472
• Report Number: 2017865-2022-07725
• Device Sequence Number: 11369515
• Product Code: DXY
• UDI-Device Identifier: 05414734006804
• UDI-Public: 05414734006804
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• 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): 06/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: 5180
• Device Catalogue Number: 5180
• Device Lot Number: 3286025
• 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: 04/02/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2011
• 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