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

Model Number	PM2134
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2022-15708 it was reported that the patient presented for explant procedure.Prior to the procedure, it was noted that the right atrial (ra) lead exhibited undersensing and high capture threshold.During the procedure, the physician attempted to disconnect the ra lead and was unable to remove the set screw.The ra lead and the pacemaker were explanted and replaced.The patient was in stable condition throughout the procedure.
Additional Manufacturer Narrative
The reported event of the atrial setscrew cannot be tightened was confirmed.Final analysis found that the setscrew was unable to tightened was due to the user not correctly inserting the wrench at angles and off center.This led the wrench not to be aligned to go into the hex insert.Lab testing shows with correct wrench insertion the torque wrench fully inserted into the inset and the setscrew could be fully tightened and loosened normally.The cause of the reported event was due to the user¿s incorrect use of the torque wrench.

• Brand Name: SUSTAIN XL DC
• 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: 15104409
• Report Number: 2017865-2022-15707
• Device Sequence Number: 5438186
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: 05414734504720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/06/2022

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: 01/31/2023
• Device Model Number: PM2134
• Device Catalogue Number: PM2134
• Device Lot Number: P000127977
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• 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: TENDRIL ST
• Patient Sex: Unknown