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

Model Number 29901

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported that the company representative received a new programmer and when connecting the power supply it would not power up the programmer or give any indication that it was working.The power cord was replaced but the programmer was still not working.A new power supply was ordered for the company representative.There was no patient involvement.

Manufacturer Narrative

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

Event Description

The programmer was returned.

Manufacturer Narrative

Product event summary: analysis confirmed the reported event, the programmer would not power up due to a defective power supply, the voltage was out of specification.

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: 4497122
• MDR Text Key: 5350353
• Report Number: 3004593495-2015-00009
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2015

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: Other
• Device Model Number: 29901
• Device Catalogue Number: 29901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/11/2015
• Supplement Dates FDA Received: 06/09/2015; 08/05/2015; 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