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

Model Number	PM2160
Medical Device Problem Codes	Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for in clinic follow-up with ventricular bradycardia.Device interrogation was attempted however, the pacemaker (pm) failed to be interrogated.On (b)(6) 2025, an electrocardiogram (ecg) was performed, noting that the pm was not providing pacing.The physician elected to explant and replace the pm.The patient condition was stable.
Additional Manufacturer Narrative
The reported event of failure to interrogate and no lv output were confirmed.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected an anomaly between the pre-casted header and titanium case.The device was cut open to enable further testing and the battery was found depleted.Feedthrough leak test was performed, indicating a device hermeticity breach.This is consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.Hybrid circuitry was tested by connecting to an external power source.Test results indicated elevated current drain, consistent with moisture damage, resulting in the reported event.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.

• Brand Name: ENDURITY 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23904098
• Report Number: 2017865-2025-1008281
• Device Sequence Number: 7732217
• Product Code: NVZ
• UDI-Device Identifier: 05414734507059
• UDI-Public: (01)05414734507059(10)P000086189(17)210228
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 04/29/2026

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: 02/28/2021
• Device Model Number: PM2160
• Device Lot Number: P000086189
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male