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

Model Number 24970A

Device Problems Device Difficult to Program or Calibrate (1496); Communication or Transmission Problem (2896)

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

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during an av node ablation, programmer telemetry timed out with an implantable pulse generator (ipg).The session was ended and the ipg was re-interrogated.There was a prolonged interrogation period as obtaining telemetry to start the interrogation was challenging.Once interrogation was complete, testing was completed without issue.Device reprogramming of the lower rate was attempted but failed.The programmer produced a ¿retry¿ message citing a telemetry issue.Telemetry was confined with icons and there was no loss of electrograms (egm) signal.The patient received a prolonged period of thirty beats per minute post node ablation.Another programmer was used to finish the procedure.The programmer remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis of the programmer's data files confirmed the timeout issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK SMARTSYNC BASE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9481771
• MDR Text Key: 171647968
• Report Number: 3004593495-2019-01310
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 02/25/2020
• 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
• Treatment: 24967 PATIENT CONNECTOR
• Patient Outcome(s): Required Intervention