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

Model Number 2090W

Device Problems Failure to Disconnect (2541); Output Problem (3005)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: manufacturer's analysis confirmed the customer comment.It was indicated that the electrocardiogram connector was loose and was the source of the interference.The printed circuit board was replaced and calibrated.The hard drive was reconfigured and loaded with updated software.Manufacturer's analysis was unable to confirm the customer comment that the head could not be removed from the programmer.The head was not in the programmer when received.It was also indicated that the display dropped and therefore the hinges were replaced.It was also indicated that there were spots in the display and therefore the display was replaced.It was also indicated that they system fan was noisy, the left keyboard hinge was broken, the keyboard was missing.The printer was loud, the lower case was worn, and the stylus tip was loose.These parts were replaced and the programmer passed final functional and systems tests.(b)(4).

Event Description

It was reported that the programmer had sixty cycle interference.The electrocardiogram cables were changed without success.It was also reported that the radiofrequency head was jammed and could not be removed from the programmer.The programmer was returned for repair.The programmer tested out of specification during manufacturer's analysis.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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5423575
• MDR Text Key: 38370910
• Report Number: 2182208-2016-00339
• Device Sequence Number: 1
• Product Code: KRG
• 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: Other
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• 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: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2002
• 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