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

Model Number 229047

Device Problem Capturing Problem (2891)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer's analysis was unable to confirm the customer comment that the analyzer was having problems with the atrial channel.The analyzer passed incoming testing.It was indicated that the front connector was loose.

Event Description

It was reported that the programmer's printer did not work and that there were problems with the atrial channel of the analyzer.The programmer and analyzer were returned for service.No patient complications have been reported as a result of this event.

• 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: 6924092
• MDR Text Key: 89719460
• Report Number: 2182208-2017-01663
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902256011
• UDI-Public: 00721902256011
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 229047
• Device Catalogue Number: 229047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2002
• 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