MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK SMARTSYNC BASE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	24970A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a implantable cardioverter defibrillator (icd) implant using the mobile programmer base, there was continuous loss of telemetry and repeated disconnections from the implanted device throughout the procedure.Telemetry loss occurred prior to the device being placed on the sterile field and continued intermittently while connecting to the icd and checking measurements.Troubleshooting steps were taken to include repositioning the base from the programmer cart to the patient table, then to a tower positioned above the patient, as well as moving the patient connector closer to the patient¿s head.It was noted that wifeless fidelity was turned off during these attempts.Despite the troubleshooting steps, telemetry remained intermittent, and the connection quality was insufficient to safely proceed with defibrillation threshold (dft) testing using the base.Therefore, the session was ended, and the procedure was completed using a legacy programmer.It was then reported that a brief loss of connection occurred once with the legacy programmer, but it reconnected immediately, and no further connection issues were observed during dft testing.No patient complications have been reported as a result of this event.Application version: 4.3.5 host tablet os version: 18.5.
Additional Manufacturer Narrative
Continuation of d10: 2090 programmer, 24967 patient connector, m01a02 mobile programmer application medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: performance data collected from the mobile programmer was received and analyzed.Analysis of the service logs found the customer comment that the mobile programmer base lost telemetry was confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CARELINK SMARTSYNC BASE
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24051350
• Report Number: 2182208-2026-00305
• Device Sequence Number: 15916514
• Product Code: OSR
• UDI-Device Identifier: 00763000201289
• UDI-Public: (01)00763000201289(11)200424
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 52 YR
• Patient Sex: Female