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

Model Number 2090W

Device Problems Device Difficult to Program or Calibrate (1496); Failure to Calibrate (2440); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment of an issue with the stylus of the programmer whilst the stylus was noted to be functional.However the stylus/cursor interaction was noted to be jumpy and the tip of the stylus was loose.The stylus and xy printed circuit board (pcb) were replaced and overlay calibrated.Analysis was able to confirm the customer comment that the system fan was noisy and it was replaced.A piece of plastic was noted to be loose inside display area and was removed.The power cord was not hospital grade and was replaced.The programmer failed analog input/output testing and the analyzer bay flex connector was cleaned and reseated then the programmer passed analog/input/output testing ten consecutive times.The hard drive was reconfigured and the software was reloaded and updated.The programmer passed all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the stylus of the programmer was inaccurate even after multiple reprogramming.It was further reported that the fan of the programmer was very loud and occasionally stopped.The programmer has been received for repair.It was further reported that 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: 9937190
• MDR Text Key: 187212690
• Report Number: 2182208-2020-00685
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994127631
• UDI-Public: 00613994127631
• 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
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 03/20/2020
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2002
• 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