MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK SMARTSYNC BASE; ANALYZER, PACEMAKER GENERATOR FUNCTION

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	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure of the leadless implantable pulse generator (ipg), the device exhibited intermittent telemetry.The device was unable to be interrogated and was unable to establish telemetry possibly due to patient's chest anatomy being too thick.The device and the delivery system was attempted, not used and was replaced.It was noted that the mobile programmer had been able to establish telemetry, interrogate and programme the ipg pre-procedure however when the ipg was implanted telemetry was unable to be established despite multiple attempts from different positions.The user ended and restarted a session to re-interrogate and despite the patient connector light displaying orange the ipg was unable to be interrogated in the patient's body.It was noted that the ipg was subsequently able to be interrogated in a bag using the mobile programmer.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: mc2vr01-delsys delivery system.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: ANALYZER, PACEMAKER GENERATOR FUNCTION
• 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: 20671843
• Report Number: 2182208-2024-04823
• Device Sequence Number: 20654287
• Product Code: DTC
• UDI-Device Identifier: 00763000688400
• UDI-Public: 00763000688400
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/13/2024

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: 10/15/2024
• Initial Report FDA Received Date: 11/13/2024
• 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: MC2VR01 IMPLANTABLE PULSE GENERATOR (CONT'D H11)
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 113 KG