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

Model Number	PM1240
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital with dyspnea.The pulse generator was unable to be interrogated.Dyspnea was possibly due to lack of pacing.The device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported events of inability to interrogate, premature discharge of battery, and no pacing were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, resulting in high current drain, consistent with moisture damage, depleting the battery and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.
Event or Problem Description
New information received noted device also exhibited no magnet response and premature discharge of battery.

• 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: 23396617
• Report Number: 2017865-2025-1003490
• Device Sequence Number: 10015797
• Product Code: NVZ
• UDI-Device Identifier: 05414734507066
• UDI-Public: (01)05414734507066(10)A000030105(17)180430
• 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: 2018
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 04/30/2018
• Device Model Number: PM1240
• Device Lot Number: A000030105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1530-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIGHT VENTRICULAR (RV) LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male