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

Model Number 2090W

Device Problems No Display/Image (1183); No Device Output (1435); Operating System Becomes Nonfunctional (2996)

Patient Problem Cardiac Arrest (1762)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Analysis summary: analysis confirmed the customer comment via the error logs and the software was reconfigured and reloaded.It was additionally noted that the power cord bay latches and the keyboard slide rails were broken and the bullet cover was missing.All were replaced.The circuit boards and mechanical parts were inspected and the device then passed all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that while a competitor was using the analyzer during a device changeout case the programmer "crashed" to a black screen without warning and was unable to provide pacing during that time.The programmer and analyzer have been returned to service.No patient complications have been reported as a result of this event.It was further reported via follow-up that the analyzer was being used to maintain cardiac support during preparation of the replacement (implantable heart) device.The analyzer then "crashed" without warning and the patient, who was pacemaker dependent went into asystole.The physician was able to plug the leads back into the old device to support the patient until the new device was able to take over.A second analyzer was available was used to finish the procedure.No further patient complications were reported.

• Brand Name: CARELINK
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7496987
• MDR Text Key: 107683887
• Report Number: 2182208-2018-00867
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00885074301440
• UDI-Public: 00885074301440
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2005
• 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
• Patient Outcome(s): Required Intervention