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

Model Number 2090AA

Device Problems Computer Software Problem (1112); Device Difficult to Program or Calibrate (1496); Problem with Software Installation (3013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

The programmer was returned to service and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Product analysis: it was also determined at analysis that the stylus worked intermittently.The programmer hard drive was reconfigured and the programmer software was reloaded and updated.All found defective parts were replaced and all identified issues were resolved.The programmer then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC CARELINK PROGRAMMER WITH ANALYZER
• 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: 13786371
• MDR Text Key: 287320583
• Report Number: 2182208-2022-00804
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090AA
• Device Catalogue Number: 2090AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2002
• 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
• Treatment: 2067L RADIOFREQUENCY HEAD