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

Model Number	PM1134
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	09/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for an initial implant.During the procedure, the physician noted the pacemaker was in backup mode.The pacemaker was replaced.The patient was stable throughout.
Additional Manufacturer Narrative
The device was received in backup mode due to electrocautery.Output was recorded and the device was re-programed and tested.The device image was analyzed and found no anomalies.The results of all electrical tests found no anomalies, including battery assessment.The voltage was above elective replacement indicator (eri) level.The longevity assessment was performed and was considered normal battery depletion.

• Brand Name: SUSTAIN XL SC
• 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: 13213856
• Report Number: 2017865-2022-00732
• Device Sequence Number: 1581350
• Product Code: NVZ
• UDI-Device Identifier: 05414734504744
• UDI-Public: 05414734504744
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/25/2022

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: 05/31/2022
• Device Model Number: PM1134
• Device Catalogue Number: PM1134
• Device Lot Number: P000112169
• 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: 12/25/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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