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

Model Number 2090W

Device Problems Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer was "not functioning well." the programmer was noted to boot up slowly, not turn on, and sometimes shutdown.The programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

Product event summary: analysis was able to confirm the customer comment that the programmer would not power up.The programmer did power up with a known good power supply.Analysis also determined that the power cord bay assembly latches were broken, both keyboard hinges were broken, the media bay door latch was missing, the display lower hinge plate was missing, the keyboard cover left side rail was broken, the display hinges were missing bullet covers, the upper display hinges were broken, and the lower case feet were worn out.All found defective parts were replaced and all other identified issues were resolved.The device then passed all functional tests.If information is provided in the future, a supplemental report will be issued.

• 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: 9488468
• MDR Text Key: 173324848
• Report Number: 2182208-2019-02313
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

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: 12/16/2019
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2006
• 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