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

Model Number	5620
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a scheduled procedure.During the procedure, the pacemaker's set screw would not tighten.The pacemaker was not used and a new one was implanted.The patient was in stable condition post-procedure.
Additional Manufacturer Narrative
The reported event of the inability to operate the screw port and fix lead normally was not confirmed.Electrical and mechanical tests were normal.Visual examination found no anomalies.Further analysis was performed, and the device exhibited normal characteristics.No anomaly was noted, all manufacturing operations have been completed and passed.

• Brand Name: ZEPHYR 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: 13170395
• Report Number: 2017865-2021-40442
• Device Sequence Number: 1765100
• Product Code: NVZ
• UDI-Device Identifier: 05414734501606
• UDI-Public: 05414734501606
• 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,Followup
• Report Date (Section B): 02/07/2022

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: 06/30/2022
• Device Model Number: 5620
• Device Catalogue Number: 5620
• Device Lot Number: S000079911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• 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: 12/18/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 01/28/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/10/2022; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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