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); Pacing Problem (1439); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Asystole (4442); Heart Block (4444)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
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 reported that during right ventricular (rv) lead placement, the patient lost conduction and experienced asystole.It was noted that pacing using the mobile programmer application pacing system analyzer (psa) was attempted after rapid lead fixation.Pacing was initiated at 90 bpm.Approximately two minutes later, a reduction in pacing rate to 60 bpm was attempted; however, the psa did not accept the rate change.It was observed that the displayed rate changed to display question mark symbols and a pop-up message appeared stating that the parameter change was not confirmed.Multiple attempts to adjust the pacing rate were unsuccessful, and pacing continued at 90 bpm.Attempts to change the pacing mode from vvi to voo resulted in the same message, with no parameter changes applied.Troubleshooting steps were taken to include confirming wireless fidelity was turned off on the host tablet and verifying that the mobile programmer and patient connector were paired.The issue persisted despite these actions.Additional troubleshooting steps were taken to include swapping the mobile programmer for a legacy programmer which was used as an alternate psa, allowing the mobile programmer application psa to be force closed and restarted.Following the restart, the mobile programmer application psa functioned as expected.The rv lead was successfully implanted and remains in use.No further patient complications have been reported as a result of this event.Application version: 4.4.2 host tablet os version: 18.5.

• 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: 24065053
• Report Number: 2182208-2026-00332
• Device Sequence Number: 9387563
• Product Code: OSR
• UDI-Device Identifier: 00763000201289
• UDI-Public: (01)00763000201289(11)191213
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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 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: 01/07/2026
• Initial Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 12/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female