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

Model Number 29901A

Device Problems No Display/Image (1183); Mechanical Problem (1384); Component Missing (2306)

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

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis : analysis confirmed display has deep scratches.Replaced display with salvaged material.Salvaged material was inspected and tested per applicable requirements.Programmer powers up with "operating system not found" error.Reloaded software.Confirmed missing "rubber pad" on case.This part does not affect functionality of the programmer and, due to lack of parts available, will not be replaced.Passed all functional, safety and systems tests.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was reported that the programmer's touchscreen is not working, and there are deep scratches in the display.In addition, there is a rubber pad missing from the upper right corner.The programmer has been 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: 9271489
• MDR Text Key: 167506339
• Report Number: 3004593495-2019-01155
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 29901A
• Device Catalogue Number: 29901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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