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

Model Number	5626
Medical Device Problem Codes	Battery Problem (2885); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented for a follow up in clinic.It was noted that the pacemaker went into backup vvi, and battery impedance problem was also observed.No intervention was performed.The patient was stable.
Event or Problem Description
New information received notes that the pacemaker was explanted and replaced on (b)(6) 2025.The patient was in stable condition.

• 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: 22768173
• Report Number: 2017865-2025-97206
• Device Sequence Number: 9289042
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: (01)05414734501712(10)2681387(17)091231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2009
• Device Model Number: 5626
• Device Lot Number: 0002681387
• Was Device Available for Evaluation?: No
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/10/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2008
• 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: 818A BIPLR LEAD (RV LEAD).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 108 KG