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

Model Number 24970A

Device Problem Pacing Problem (1439)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a programmer application froze after attaching the right ventricular (rv) lead and measuring the r waves without issue.The freeze was experienced when an attempt to pace and test for rv threshold was made, it was also noted that the screen displayed three question marks.Further attempts to pace were made however were unsuccessful and no output from the programmer was noticed.After closing and restarting the application twice the issue resolved.The programmer remains in use.No patient complications were reported as a result of the event.

Manufacturer Narrative

Product analysis: the following complaint(s) were investigated: it was reported that there was an issue with the mobile programmer base (pacing no output).Analysis of the mobile application logs indicated a usability issue.Further action was not required because an existing corrective action or investigation is applicable.The issue was observed at the phase, when multiple downlink requests carrying the programmed parameters failed due to the no response from the pacing system analyzer (psa) device (the request was delivered there but the psa didn't respond in 10 seconds).No work around exists.The user should end the session and re-connect.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK SMARTSYNC BASE
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10389657
• MDR Text Key: 202407093
• Report Number: 3004593495-2020-00840
• Device Sequence Number: 1
• Product Code: DTC
• UDI-Device Identifier: 00763000201289
• UDI-Public: 00763000201289
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR