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

Model Number 2090

Device Problems No Display/Image (1183); Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the customer comment that the programmer would not turn on and had a burned smell.It was indicated that the main printed circuit board (pcb) was out of specification.The programmer was repaired and returned to service.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer monitor stayed black after attempting to turn it on.There was also a smell of burnt cable.The programmer was returned for service.There was no patient involvement.

• Brand Name: CARELINK PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9197323
• MDR Text Key: 162477659
• Report Number: 2182208-2019-01853
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2019

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: 10/03/2019
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2005
• 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