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

Model Number 2090

Device Problems Crack (1135); No Display/Image (1183)

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

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that the programmer was repaired in the field by a company representative for a cracked/faulty touchscreen.Information was requested for more details regarding the screen issue but no more information was available to date.The programmer is still in use.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: 5316496
• MDR Text Key: 34739573
• Report Number: 2182208-2015-04680
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• 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