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

Model Number 2090

Device Problems Device Difficult to Program or Calibrate (1496); Component Missing (2306); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: analysis confirmed the customer comment of an issue with the stylus and noted that the stylus was actually not working at all.Analysis also confirmed the missing keyboard and a loose electrocardiogram (ecg) connector on the link electronic module (lem) board.The keyboard slide cover was missing, the keyboard hinges were broken, the power cord bay was damaged and the system fan was noisy.Both the stylus and the lem board were replaced and calibrated, and the keyboard, keyboard slide covers, keyboard hinges, power cord bay and system fan were all replaced.The programmer passed its final functional and system tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer stylus was working intermittently.Also, the programmer was missing the keyboard and the electrocardiogram (ecg) port was not working.The cable for the ecg port had to be pushed down hard in order to get a clean signal.The programmer was returned for service.There was no patient involvement.

• 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: 7093767
• MDR Text Key: 94645277
• Report Number: 2182208-2017-02089
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994175403
• UDI-Public: 00613994175403
• 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: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 11/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2007
• 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