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

Model Number	5376
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for a follow-up on (b)(6) 2022.Upon interrogation, it was noted that the pacemaker was in backup mode.Attempts were made to re-program the device which were unsuccessful.The physician explanted and replaced the pacemaker on (b)(6) 2022.There were no adverse consequences to the patient.

• Brand Name: IDENTITY XL DR
• 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: 13703282
• Report Number: 2017865-2022-04847
• Device Sequence Number: 12355846
• Product Code: DXY
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 12/31/2008
• Device Model Number: 5376
• Device Catalogue Number: 5376
• Device Lot Number: 0002116706
• Was Device Available for Evaluation?: No
• 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: 02/15/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ISOFLEX; ISOFLEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 82 KG