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

Model Number	PM1134
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during initial implant, a patient's pacemaker exhibited no low voltage outputs even after multiple attempts to pace.The pacemaker was not used and another pacemaker was used to completed the procedure.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of no pacing was confirmed.The device had no output and no telemetry upon receipt.Device was cut open and battery voltage was measured to be at normal range of operation.Analysis performed in lab could not determine cause of device failure and device was sent for external analysis.Further analysis was performed and cause of no pacing was found to be due to an anomalous component on the hybrid.A longevity estimation was performed and device was found to have appropriate remaining longevity.

• 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: 12005406
• Report Number: 2017865-2021-21972
• Device Sequence Number: 13728020
• 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): 04/26/2022

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: 02/28/2022
• Device Model Number: PM1134
• Device Catalogue Number: PM1134
• Device Lot Number: P000109085
• 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: 05/27/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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