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

Model Number 2090

Device Problems Break (1069); Mechanical Problem (1384); Component Missing (2306); Computer Operating System Problem (2898); Connection Problem (2900); Device Contamination with Chemical or Other Material (2944); Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer¿s analysis confirmed the customer comments that the device had software update issues, a missing power cord, a broken power cord bay, would not stay closed, was located in a dusty area, and had broken eject levers.It was also noted that the emergency button was nonfunctional, and the device failed incoming tests.All found defective parts were replaced and all other identified issues were resolved.The device passed final functional and system tests.

Event Description

It was reported that the programmer was accidentally unplugged during the software distribution network session update process, resulting in the programmer becoming unable to re-boot to the start screen.The programmer would not update via the software distribution network, as well.It was also reported that the eject/push button key at the ethernet card slot was broken off, and it was questioned whether or not the card was making contact with the terminals.Furthermore, there was no power cord, back panel latches were broken, the programmer would not stay closed, and the programmer was located in a very dusty location.The programmer has been returned for repair, and a request was made for a functionality test and internal cleaning.There was no patient involvement.It was further reported that the returned programmer subsequently tested out of specification during manufacturer¿s analysis.

• 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: 6624738
• MDR Text Key: 77257959
• Report Number: 2182208-2017-00781
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994581594
• UDI-Public: 00613994581594
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 02/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2003
• 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