MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PROGRAMMER, PACEMAKER

Model Number 29901

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was unable to confirm that the programmer was perpetually rebooting.However, analysis noted that the programmer was not booting up normally.The programmer would boot up to the please wait screen and did not advance past that point.The software was reconfigured and reloaded.Analysis also noted that the rubber covers for the ethernet port were missing.The device passed final functional and system tests.No other anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was perpetually rebooting.The programmer was returned for service.There was no patient involvement.

• Brand Name: CARELINK ENCORE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7457250
• MDR Text Key: 106405538
• Report Number: 3004593495-2018-00304
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169369030
• UDI-Public: 00643169369030
• 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
• Report Date: 04/24/2018

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: Health Professional
• Device Model Number: 29901
• Device Catalogue Number: 29901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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