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

Model Number	PM1110
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during implant procedure that the set screw of the pacemaker could not be tightened.The pacemaker was successfully exchanged.The patient was stable and asymptomatic.
Additional Manufacturer Narrative
The reported complaint of loose or intermittent connection was not confirmed.Analysis found the user of the torque wrench made multiple incorrect insertions through the septum and into the setscrew inset.The incorrect wrench insertions punched-out numerous pieces of the septum that filled the setscrew inset and caused the torque wrench to slip around and cause stripping to the inset walls.No device anomalies were found.The problem was caused by the user¿s incorrect use of the torque wrench.Device is electrically normal above eri.

• Brand Name: ACCENT SR
• 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: 15158027
• Report Number: 2017865-2022-16744
• Device Sequence Number: 17445086
• Product Code: NVZ
• UDI-Device Identifier: 05414734502740
• UDI-Public: 05414734502740
• 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): 10/26/2022

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: 01/31/2023
• Device Model Number: PM1110
• Device Catalogue Number: PM1110
• Device Lot Number: S000083700
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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
• Patient Sex: Unknown