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

Model Number	5626
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the following day after implantation, on (b)(6) 2026, that there was high capture threshold on the right ventricular (rv) lead.On (b)(6) 2026, imaging was performed and revealed that the rv lead had dislodged.On (b)(6) 2026, the physician elected to reposition the rv lead.During the procedure, it was noted that the set screw of the pacemaker (pm) was unable to be tightened and after multiple attempts the septum of the pm had dislodged and a screw was noted to be missing.The physician elected to explant the pm and implant a new one to complete the procedure.The patient condition was stable following the procedure.

• Brand Name: ZEPHYR XL SR
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24268610
• Report Number: 2017865-2026-02391
• Device Sequence Number: 10714448
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: (01)05414734501712(10)P000228874(17)260930
• 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: 2026
• Device Explanted Year: 2026
• 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): 06/26/2026

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: 09/30/2026
• Device Model Number: 5626
• Device Lot Number: P000228874
• 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: 01/17/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 06/25/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/14/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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