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

Model Number 2090

Device Problem Failure to Interrogate (1332)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was unable to confirm the customer comment that the programmer was unable to read any pacer.It was noted during analysis that the programmer failed incoming test due to a defective power supply, the power supply was replaced.Analysis also noted that the stylus was bent but functional, the keyboard hinges on both left and right were broken and bullet assay on left and right were missing.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was unable to read any pacer.The device has been returned for service.No patient complications have been reported as a result of this event.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

• Brand Name: CARELINK PROGRAMMER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10317280
• MDR Text Key: 200202023
• Report Number: 2182208-2020-01335
• 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
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 06/04/2020
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2004
• 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