MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number 29901

Device Problems Computer Software Problem (1112); Failure to Interrogate (1332); Power Problem (3010)

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

Event Date 03/25/2015

Event Type  malfunction  

Event Description

It was reported that during a device interrogation with a programmer, the customer was unable to establish telemetry with the device.The programmer then restarted itself and displayed an error.The error cleared once the programmer was restarted.It was also reported "serious programmer error" code kept coming up.The programmer was returned for repair.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: analysis confirmed the reported event; the programmer powered up and interrogated, however, errors found in the programmer error log.It was noted interrogation was intermittent.

Manufacturer Narrative

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

• Brand Name: CARELINK ENCORE
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4830614
• MDR Text Key: 16564211
• Report Number: 3004593495-2015-00122
• Device Sequence Number: 1
• Product Code: OSR
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2015

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: 04/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided; 09/23/2015
• Supplement Dates FDA Received: 12/09/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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