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

Model Number 2090

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the programmer's reported issues.It was indicated that the power supply was defective.It was also indicated that the link electronic module (lem) 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 when the programmer was turned on there was a loud sound and then the smell of something burning.The programmer was returned for service.There was no patient involvement.

• 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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8021006
• MDR Text Key: 125605611
• Report Number: 2182208-2018-01979
• 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: 10/30/2018

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: 10/16/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2013
• 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