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

Model Number 2090W

Device Problems Device Emits Odor (1425); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

It was reported that the programmer's printer smelled as though it were burning when it was trying to print.The programmer was returned for service.No patient complications have been reported as a result of this event.It was further reported that the programmer subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.

Manufacturer Narrative

This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis was unable to confirm the customer comment that the printer smelled as though it were burning, however the power supply had a burnt smell and the device would not power up and therefore the power supply was replaced.Analysis also found that the upper hinge plate as well as the upper and lower bullets were scuffed up and all were replaced to resolve.

• 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: 4311382
• MDR Text Key: 18067062
• Report Number: 2182208-2014-03209
• 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: 10/02/2014

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: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 12/09/2014
• 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: 2067 RADIOFREQUENCY PROGRAMMER HEAD