MAUDE Adverse Event Report: ABBOTT 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5356
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, prior to device replacement for normal elective replacement indicator (eri) the device was unable to be interrogated using inductive telemetry.The device was replaced as anticipated for normal eri.The patient was stable.
Additional Manufacturer Narrative
The reported event of failure to interrogate was not confirmed.The device was received from the field at elective replacement indicator (eri) level which was reached post-explant.The device trigged a false eri alert while implanted consistent with auto-capture and high output mode condition.Electrical and mechanical analysis performed indicated normal functionality and no interrogation issue found.Further battery assessment performed at various pulse amplitude measured current level within normal range, and no interrogation issue was found.Visual inspection of the header and connectors did not find any anomaly that could cause communication issues.Longevity assessment was performed based on average drain current and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• 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: 17924141
• Report Number: 2017865-2023-48497
• Device Sequence Number: 11508842
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 11/17/2023

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: 07/31/2013
• Device Model Number: 5356
• Device Lot Number: 3585443
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2012
• 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