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

Model Number 2090

Device Problems Computer Software Problem (1112); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer generated an error code indicating that the "device driver is stuck in an infinite loop" while attempting to be updated.It was noted that the error appeared even if the power was turned off and then turned on again.It was further reported that eventually another error indicating "programmer has over heated" appeared, and it turned off automatically.The device has been returned to service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customers comment, via the error logs, that the programmer generated an error code indicating.The micro processor unit (mpu) board was replaced.The power supply was replaced as a preventative measure.System fan was not spinning.The system fan was replaced.There was spots in right side of display.The lcd (liquid crystal display) was replaced.Broken upper display hinge was noted during analysis and were replaced.The handle covers were cracked.Replaced handle covers.Programmer tested out of specification on "audio loop back" functional test.The microphone connector was restated as a result.The hard drive was re imaged, reloaded and updated with the latest software.The device then passed all final functional and systems tests.No other anomalies were found.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 PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10559033
• MDR Text Key: 207699908
• Report Number: 2182208-2020-01964
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2067 RADIOFREQUENCY HEAD; 2067 RADIOFREQUENCY HEAD