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

Model Number 2090

Device Problem Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis of the programmer was able to confirm the customer comments that the programmer could not be updated with software and would not print to universal serial bus (usb).The programmer was reloaded and updated with software.Analysis also noted that the floppy drive did not read disks, stylus tips was pulling apart but functional and printer keypad 50 would not print.The programmer failed device test due to thermal sensor.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was unable to update via the universal serial bus (usb).The device was returned for service and subsequently tested out of specification during manufacturers analysis.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: 10558988
• MDR Text Key: 207703378
• Report Number: 2182208-2020-01963
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994175397
• UDI-Public: 00613994175397
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2020

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
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2006
• 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
• Treatment: 2067 RADIO FREQUENCY HEAD, 229047 ANALYZER