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

Model Number 2090

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer¿s analysis was unable to confirm the customer comments regarding an inability to load software on the programmer.It was found, however, that the programmer failed incoming functional tests due to excessive internal corrosion.The programmer was scrapped.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer, originally returned due to the inability to load software after multiple attempts, subsequently tested out of specification during manufacturer¿s analysis.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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8612869
• MDR Text Key: 145147406
• Report Number: 2182208-2019-00896
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• 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: 03/19/2019
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2004
• 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