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

Model Number 2090

Device Problems No Display/Image (1183); Device Difficult to Program or Calibrate (1496); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the stylus would not stay calibrated.The stylus was replaced and the connector was reseated between the overlay and the xy board and the stylus was calibrated.Reconfigured hard drive, reloaded and updated software and the device then 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 programmer's "pen" (stylus) did not work.It was noted that an alternative stylus was used with the same result.The programmer was returned for service.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: 10598587
• MDR Text Key: 208929703
• Report Number: 2182208-2020-02115
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994434937
• UDI-Public: 00613994434937
• 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: 09/29/2020

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: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2009
• 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
• Treatment: 2067L RADIOFREQUENCY HEAD, 229047 ANALYZER