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

Model Number	5286
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported the asymptomatic patient presented in clinic.Upon interrogation, it was observed the pacemaker had evidence of premature battery depletion.No known intervention took place to address this issue.The patient was stable.
Event or Problem Description
New information received indicated the pacemaker was explanted and replaced on (b)(6) 2021.The patient was stable.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was confirmed.Electrical tests performed after replacing the battery indicated normal functionality.Initially, high current was detected, however further evaluation after replacing the power source could not duplicate the high current which depleted the battery prematurely.The final cause of premature depletion was a latch up condition caused by an unknown component.

• Brand Name: IDENTITY ADX XL
• 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: 11566343
• Report Number: 2017865-2021-12810
• Device Sequence Number: 3071917
• Product Code: DXY
• UDI-Device Identifier: 05414734006828
• UDI-Public: 05414734006828
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: 5286
• Device Catalogue Number: 5286
• Device Lot Number: 4745099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 01/19/2022
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 08/30/2021; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2014
• 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