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

Model Number 29901A

Device Problems Computer Software Problem (1112); Operating System Becomes Nonfunctional (2996); Unexpected Shutdown (4019)

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

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during atrial sensing testing for an implantable pulse generator (ipg) two separate programmers displayed an error " indicating "serious programmer error" and shut down.Additionally there was a message generated which directed the user to reprogram the ipg from dddr to vvir.The patient's follow-up was rescheduled for the following day.Both programmers remain in use.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: 9252695
• MDR Text Key: 175246144
• Report Number: 3004593495-2019-01132
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/29/2019
• 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