MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 2090W

Device Problems Display or Visual Feedback Problem (1184); Problem with Software Installation (3013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis confirmed the customer comment that the programmer software was unable to be updated.It was found during incoming functional tests that the programmer was unable to update software via software distribution network (sdn) or universal serial bus (usb) media.Additional analysis showed that the stylus was missing and it was observed that the replacement stylus was non responsive to the cursor at horizontal lines on the touchscreen.The overlay was replaced and the stylus recalibrated to resolve.It was also found that the rear display cover was damaged and the system fan was noisy.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.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 Description

It was reported that the programmer software was unable to be updated.The programmer which was returned for evaluation subsequently tested out of specification during manufacturer's assessment.There was no patient involvement.

• Brand Name: CARELINK PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18984806
• MDR Text Key: 338671584
• Report Number: 2182208-2024-01309
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/22/2022
• Device Model Number: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1