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

Model Number 2090

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Power Problem (3010)

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

Event Date 12/29/2014

Event Type  malfunction  

Event Description

It was reported that the programmer made a "popping noise" when plugged in and that there was a smoke smell when it was turned on.The programmer was returned for service.No patient complications have been reported as a result of this event.

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).

Manufacturer Narrative

Product event summary: analysis was unable to confirm the customer comment of a "popping" noise however it did confirm that the power supply smelled burnt and it was noted that the programmer would not power up and its power supply was replaced.Analysis further noted that four hinge plate screws were missing, the latch tabs were broken off of the power cord bay door, the stylus was missing and the electrocardiogram connector on the link electronic module (lem) printed circuit board (pcb) was loose.All found defective parts were replaced and the lem pcb was also calibrated.

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 st 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: 4496825
• MDR Text Key: 5344456
• Report Number: 2182208-2015-00206
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided; 01/26/2015
• Supplement Dates FDA Received: 04/09/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 229047 SOFTWARE ANALYZER