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

Model Number	PM1240
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the electronics performance indicator (epi), an alert was received by the clinician and awaiting device explant.  further information was requested, but not yet available.The patient condition was not reported.
Event or Problem Description
New information indicates that the pacemaker was explanted replaced on (b)(6) 2026.The patient condition was stable.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device was above elective replacement indicator (eri) level upon receipt.Visual inspection of the header found no anomaly related to the field concern.Review of the device image indicates auto-capture was enabled, consistent with electronics performance indicator (epi) triggered.When automatic settings are programmed, such as auto-capture, the device output would adjust itself to accommodate the patient¿s needs for pacing.Electrical and mechanical analysis performed indicated normal functionality.Further battery assessment at various pulse amplitudes found normal current levels and no indication of premature battery depletion noted.Longevity assessment was performed, and the device was in normal range of operation with appropriate remaining longevity.

• Brand Name: ASSURITY SR RF
• 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: 24548347
• Report Number: 2017865-2026-04857
• Device Sequence Number: 12155960
• Product Code: NVZ
• UDI-Device Identifier: 05414734507066
• UDI-Public: (01)05414734507066(10)A000006089(17)161130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2026

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: 11/30/2016
• Device Model Number: PM1240
• Device Lot Number: A000006089
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 04/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/08/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2015
• 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: 1488TC/58 PKG/STER; 1888TC/52 SDX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male