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

Model Number 2090

Device Problems No Display/Image (1183); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was a burning smell coming from the programmer and the screen would intermittently go blank.It was recommended that the programmer be returned but its current status is unknown.There was no patient involvement.

Manufacturer Narrative

Product analysis: manufacturer's analysis was unable to confirm the customer comment that there was a burning smell coming from the programmer and the screen would intermittently go blank.Testing of the programmer found no abnormalities.It was indicated that the upper hinges were worn.The programmer was repaired and returned to service.If information is provided in the future, a supplemental report will be issued.

Event Description

The programmer was returned for service.

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, 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: 7747599
• MDR Text Key: 116094147
• Report Number: 2182208-2018-01414
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/17/2018; 08/08/2018
• Supplement Dates FDA Received: 08/22/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2002
• 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