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

Model Number 2090AA

Device Problem Programming Issue (3014)

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

Event Date 03/05/2015

Event Type  malfunction  

Event Description

It was reported that the programmer would not start.The programmer was returned for service.No patient complications have been reported as a result of this event.

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: analysis confirmed the customer comment that the programmer would not start, it did not proceed to a functioning screen which would allow interrogation.A reconfiguration was completed and the software reloaded to resolve.It was further noted that the stylus tip was separating from the main pen body and that the system fan was intermittently noisy.Both the stylus and the fan were replaced.(b)(4).

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC INC.; 8200 coral sea st ne; mounds view,mn 5511 2
• 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: 4829102
• MDR Text Key: 5838821
• Report Number: 2182208-2015-01514
• 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: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090AA
• Device Catalogue Number: 2090AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2003
• 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
• Treatment: 2067 RADIOFREQUENCY PROGRAMMER HEAD