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

Model Number 2090

Device Problems Mechanical Problem (1384); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis:analysis confirmed the customer comment that the media bay door is broken.The media bay door was replaced.The card eject buttons were broken causing combo card removal to be difficult.The card reader was replaced.The stylus functioned intermittently,a good stylus consistently functioned as required.The stylus was replaced and calibrated.It was confirmed that the universal serial bus (usb) port accepts a usb drive that will save printed document format (pdf) files.Reconfigured hard drive and reloaded software.The programmer was cleaned.The device then passed all functional and system tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer floppy disk drawer was broken and that the "combo" card was unable to be removed.It was also requested to check the ability of the universal serial bus (usb) to save.The device was returned into servicing.There was no patient involvement.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

• 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: 10547049
• MDR Text Key: 207335157
• Report Number: 2182208-2020-01921
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• 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: 08/14/2020
• Date Manufacturer Received: 08/20/2020
• 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: 2067L RADIOFREQUENCY HEAD, 229047 ANALYZER