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

Model Number 29901A

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer crashed.On reboot, a screen appeared requesting that a universal serial bus (usb) be used to install the operating system (os).Reboot attempts did not clear the message.The programmer is expected to be returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was unable to confirm that the programmer crashed and that a screen appeared requesting installation of the operating system on reboot attempts.Analysis noted that the programmer would boot up successfully with a battery or a known good power supply and would interrogate appropriately with a known good radiofrequency head.The drive was reloaded and the software was updated as preventative measures.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2019: it was further reported that the programmer was returned for service.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8628641
• MDR Text Key: 145664390
• Report Number: 3004593495-2019-00475
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169763548
• UDI-Public: 00643169763548
• 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,Followup
• Report Date: 09/20/2019

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: 29901A
• Device Catalogue Number: 29901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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