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

Model Number	24970A
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were pairing issues between the mobile programmer base and the mobile programmer application.It was noted that when pairing was achieved, connection was intermittently lost and capture was not displayed accurately, or display of capture was delayed.Troubleshooting steps were taken to include forgetting the base in the host tablet bluetooth settings and re-pairing it within the mobile programmer application.After successful pairing, the analyzer was launched and a pop-up message appeared stating, ¿unable to retrieve data.No connection to base,¿ despite the base remaining shown as paired within the application.No patient complications have been reported as a result of this event.Application version: 4.5.2 host tablet os version: 26.2.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was further reported that the mobile programmer was not reading the cables during lead testing.Additional troubleshooting steps were taken to include swapping out the application which failed to resolve the issue, resulting in the necessity to swap out the mobile programmer to complete the case.Application version: 4.5.2 host tablet os version: 26.2.
Additional Manufacturer Narrative
Correction: additional codes 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 there was a pairing difficulty between the mobile programmer base and the mobile programmer application was confirmed.Analysis of the service logs found the customer comment that mobile programmer lost connection and there was a display of capture issue was confirmed.Analysis of the service logs found the customer comment that there was a no connection to the base diagnostic message displayed despite the base appearing as connected 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: b.2.3 date of event: g3 (initial aware date = (b)(6) 2026).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: 24312531
• Report Number: 2182208-2026-02228
• Device Sequence Number: 20052568
• Product Code: OSR
• UDI-Device Identifier: 00763000201289
• UDI-Public: (01)00763000201289(11)190724
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2026

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: Other
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/16/2026; 03/24/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/12/2026; 03/18/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2019
• 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
• Patient Age: 81 YR
• Patient Sex: Female