MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC; ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number 24970A

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591)

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

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that upon lead analysis, sensing was able to be checked; however, when proceeding to pacing, the application crashed with an error message.Exiting the application and relaunching was required.After continuing through the reset window, the user was able to complete the lead analysis.The mobile programmer application remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the reported out of specification issue with the mobile programmer application was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK SMARTSYNC
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7103366
• MDR Text Key: 94506021
• Report Number: 3004593495-2017-00789
• Device Sequence Number: 1
• Product Code: DTC
• UDI-Device Identifier: 00643169868540
• UDI-Public: 00643169868540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

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: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 12/10/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 02/08/2018
• Date Device Manufactured: 04/28/2017
• 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