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

Model Number 2090W

Device Problem Programming Issue (3014)

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

Event Date 04/24/2015

Event Type  malfunction  

Event Description

It was reported that the programmer changed over into emergency vvi pacing mode without anyone touching the programmer.It was originally believed to be the analyzer however the analyzer was changed out and the issue persisted.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.(b)(4).

Manufacturer Narrative

Product event summary: analysis was not able to confirm the customer comment that the programmer went into emergency vvi pacing mode without the programmer being touched, it did not enter into emergency vvi unless the button was pressed.Analysis did find that the system fan was noisy and that the electrocardiogram connector on the link electronic module (lem) board was loose.Both the fan and the lem board were replaced and the board was calibrated as well.

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 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: 4831486
• MDR Text Key: 20448871
• Report Number: 2182208-2015-01639
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• 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: 04/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 2067L RADIOFREQUENCY PROGRAMMER HEAD