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

Model Number 2090

Device Problems Signal Artifact/Noise (1036); Device Difficult to Program or Calibrate (1496)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2020

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 "startup buzzer sounds three times.Usually (there are) two startup sounds." it was also noted that "the point position of the touch screen is failure." the programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was unable to confirm three beeps at startup; programmer consistently beeped one time during boot up.It was noted that there was a lag/skip with the cursor in some areas of the overlay.Replaced bezel overlay assembly and calibrated with stylus.Reloaded and updated software.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.Device passed all final functional and systems tests.

• 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: 9780763
• MDR Text Key: 186837108
• Report Number: 2182208-2020-00420
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• 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: 02/28/2020
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2003
• 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