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

Model Number	5157M/S
Medical Device Problem Codes	Failure to Capture (1081); Pacemaker Found in Back-Up Mode (1440); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic with pocket stimulation.Upon interrogation, it was found that the pacemaker went into backup operation and exhibited failure to capture.No intervention was performed as the pacemaker failed to be restored.Patient condition was stable and the patient would continue to be monitored.

• Brand Name: ADX 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: 14002236
• Report Number: 2017865-2022-07059
• Device Sequence Number: 11870405
• Product Code: DXY
• UDI-Device Identifier: 05414734006774
• UDI-Public: 05414734006774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 06/30/2005
• Device Model Number: 5157M/S
• Device Catalogue Number: 5157M/S
• Device Lot Number: 0002323039
• 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: 03/16/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2003
• 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: LEAD
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 60 KG