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

Model Number 2090

Device Problems Device Difficult to Program or Calibrate (1496); Component Missing (2306); Failure to Calibrate (2440); Inadequate User Interface (2958)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cursor on the display screen of the programmer did not align with the stylus; the stylus was changed and software calibration was performed without success.It was also noted that the programmer was missing screws.The programmer is expected to be returned for repair.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was able to confirm the reported stylus and cursor misalignment and the missing screws.Analysis also noted that the programmer was missing the stylus.A stylus was added and the connection between the printed circuit board (pcb) and the overlay was cleaned and reseated and the stylus was successfully calibrated.The hard drive was reconfigured, and the software was reloaded and updated.The device passed final functional and system tests.No other anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the programmer was returned for repair.

• 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: 7906779
• MDR Text Key: 121754086
• Report Number: 2182208-2018-01745
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• 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: 10/08/2018
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2010
• 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