MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5180
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Codes	Discomfort (2330); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented to clinic for follow up.The device was unable to be interrogated and the physician alleged premature battery depletion of the pacemaker.The physician elected to explant and replace the pacemaker.The patient was discharged from the hospital after the procedure.
Additional Manufacturer Narrative
Correction: section b5: updated to reflect the patient symptoms noted correction: section h6: added health effect - clinical code of discomfort and syncope/fainting.
Event or Problem Description
It was reported that a patient presented to clinic due to symptoms of physical discomfort and syncope.The device was unable to be interrogated and the physician alleged premature battery depletion of the pacemaker.The physician elected to explant and replace the pacemaker.The patient was discharged from the hospital after the procedure.
Additional Manufacturer Narrative
Correction: h6 - updated type of investigation, investigation findings, and investigation conclusions codes for non-device return.
Additional Manufacturer Narrative
The reported events of of early battery depletion and failure to interrogate were not confirmed.The device was received in back up mode.Analysis performed did not find any anomalies, with battery voltage at eol.Longevity assessment was performed and device has exceeded projected longevity.

• Brand Name: IDENTITY ADX SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14060419
• Report Number: 2017865-2022-07520
• Device Sequence Number: 17298375
• Product Code: DXY
• UDI-Device Identifier: 05414734006804
• UDI-Public: 05414734006804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 5180
• Device Catalogue Number: 5180
• Device Lot Number: S000030210
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 06/06/2022; 08/11/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 04/12/2022; 06/06/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2017
• 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