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

Model Number 29901A

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was unable to confirm the report that the programmer would shut down.The software was reloaded as a preventive measure.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 shut down during patient sessions.It was noted that the programmer was plugged in continuously.The programmer was returned for service.No patient complications have been reported as a result of this event.

• Brand Name: CARELINK ENCORE PROGRAMMER
• 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: 9007616
• MDR Text Key: 158814201
• Report Number: 3004593495-2019-00936
• 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
• Report Date: 09/12/2019

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: 08/21/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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