MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number H403023

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

One workmate¿ claris¿ ep-4¿ cardiac stimulator was returned.Visual inspection of the returned stimulator indicated normal wear on the exterior chassis.It was verified all connectors, switches and labels appeared to have no physical damage.All mounting hardware was secured and all socketed ic (integrated circuit) components were fully seated.The unit was subject to extended simulated pacing on multiple power cycles with no anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the reported self-test issue and subsequent procedure cancellation could not be conclusively determined.

Event Description

During an electrophysiology procedure, the stimulator would not pass the self-test and the procedure was cancelled.The cables and connections were checked without resolution so the procedure was rescheduled for a later date.There were no adverse consequences to the patient due to the cancellation.

• Brand Name: WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8487122
• MDR Text Key: 141050813
• Report Number: 2184149-2019-00044
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151911
• 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
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Lot Number: 4638335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other