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

Model Number	5820
Medical Device Problem Codes	Loose or Intermittent Connection (1371); No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient presented for implant procedure.During surgery, it was discovered the pacemaker exhibited no pacing output and the atrial set screw could not be tightened.The physician elected to complete the procedure with a different pacemaker.The patient was in stable condition.
Event or Problem Description
New information received noted the screw could not be tightened due to an error in the operation of the torque wrench.
Additional Manufacturer Narrative
The reported complaint of loose or intermittent connection is confirmed.Complaint of no output was not confirmed.The pacemaker was returned for analysis.Analysis found septum material in the setscrew inset preventing torque wrench engagement in order to properly tighten the setscrew, this is consistent with incorrect insertion of torque wrench due to user error.Visual examination of the header was performed and no anomaly was noted.Pacing, telemetry and output function of the device were analyzed and no anomaly was noted.Longevity estimation was performed and device was found to have appropriate longevity remaining.

• Brand Name: ZEPHYR DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17553239
• Report Number: 2017865-2023-37783
• Device Sequence Number: 20034137
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: 11/30/2023
• Device Model Number: 5820
• Device Lot Number: 8572175
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 11/13/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/23/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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