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

Model Number 2090

Device Problems Break (1069); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis summary: analysis was unable to confirm nor reproduce the customer comment that the programmer booted down while in use, it passed its incoming vxi testing and no error was found in the logs.It was noted that the cord door latch tab was broken as was the left keyboard hinge.The cord bay and the keyboard hinge were both replaced.Analysis did confirm the customer comment that the handle was broken and the handle was replaced.The programmer passed all console and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer boots down while in use.It was additionally noted that the handle was broken.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: 7257772
• MDR Text Key: 99892535
• Report Number: 2182208-2018-00264
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

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: 12/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2002
• 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