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

Model Number 24970A

Device Problems Pacing Problem (1439); Impedance Problem (2950)

Patient Problem Cardiac Arrest (1762)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after the physician requested a lead impedance check and this check was initiated using the mobile programmer application the pacing was lost, causing asystole.Upon ending the test pacing was resumed.The programmer was changed out and a different model was brought in to recheck the test.It was noted that the test was unable to be performed until the pace and sense polarities were programmed but that then the test was able to be performed without any change in heart rhythm.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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: 9010340
• MDR Text Key: 158811619
• Report Number: 3004593495-2019-00940
• Device Sequence Number: 1
• Product Code: DTC
• UDI-Device Identifier: 00643169957657
• UDI-Public: 00643169957657
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/02/2019
• Date Device Manufactured: 12/07/2018
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 89 YR