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

Model Number	PM1160
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's pacemaker exhibited diagnostics anomaly.No intervention or adverse patient effects were reported.
Event or Problem Description
New information received notes that the patient presented to the clinic for a scheduled follow up.The patient's pacemaker exhibited diagnostics anomaly potentially due to the device had not been checked in five years.The patient's data was reinputted and the patient had no adverse consequences.
Additional Manufacturer Narrative
Correction-section g3: the missing date received by manufacturer in mdr-2025-24374-01 was 19 jun 2025.

• Brand Name: ENDURITY 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: 22138502
• Report Number: 2017865-2025-75374
• Device Sequence Number: 7122487
• Product Code: NVZ
• UDI-Device Identifier: 05414734507042
• UDI-Public: (01)05414734507042(10)S000016037(17)170731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: 07/31/2017
• Device Model Number: PM1160
• Device Lot Number: S000016037
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided; 06/26/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/23/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2016
• 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