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

Model Number 2090

Device Problems Computer Software Problem (1112); Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: manufacturer's analysis was unable to replicate the customer comment that the programmer crashed upon device interrogation, however, it was confirmed that there was a system error in the error logs.The programmer was repaired and returned to use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer crashed upon device interrogation and had a system error.The programmer was returned for service.No patient complications have been reported as a result of this event.

• 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: 8655846
• MDR Text Key: 146642990
• Report Number: 2182208-2019-01001
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994434937
• UDI-Public: 00613994434937
• 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: 05/30/2019

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: 05/09/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2009
• 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