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

Model Number 2090

Device Problems Electrical /Electronic Property Problem (1198); Device Difficult to Program or Calibrate (1496); Power Problem (3010)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/04/2016

Event Type  malfunction  

Event Description

It was reported that the programmer activated emergency pacing while the physician was attempting to change a sensing parameter on a pacemaker, and "a lot of parameters was turn in interlock mode." the patient felt bad for a moment because they were not used to being paced in the ventricle only.The physician then needed to re-program the entire device.It was also reported that the programmer re-booted itself many times over previous weeks.The programmer has been returned to service.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Manufacturer¿s analysis could not confirm the customer comments that the emergency pacing mode of the device was activated, or that the device re-booted itself.However, it was noted that the device failed an incoming test, indicative of a problem with the link electronic module (lem) board.The lem board was replaced, and the power supply was replaced as a preventive measure.Analysis also noted that the hinges would not hold the display up, there were missing and loose hinge plate screws, and the printer of the device was noisy.All found defective parts were replaced and all other identified issues were resolved.The device passed final functional and system tests.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6164559
• MDR Text Key: 62191896
• Report Number: 2182208-2016-02901
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• 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: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2002
• 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
• Patient Outcome(s): Required Intervention