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

Model Number 2090W

Device Problems Loss of Power (1475); Unexpected Shutdown (4019)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: manufacturer's analysis was unable to confirm the customer comment that the programmer crashed.The programmer passed incoming functional testing.However, errors were found in the programmer logs.It was also indicated that the keyboard and a latch were broken.The programmer was repaired and returned to service.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer would crash when attempting to check device.The programmer was returned to service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• 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: 7704277
• MDR Text Key: 114802066
• Report Number: 2182208-2018-01322
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994127631
• UDI-Public: 00613994127631
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2002
• 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