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

Model Number	H403023
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
Related manufacturer reference: 2184149-2020-00056, 2184149-2020-00057.During a procedure, a saline bag ruptured causing water damage to devices.The procedure was cancelled.The claris ep4 stimulator had evidence of saline fluid damage and had fluid inside the unit.The signals were intermittent and could not be repaired.The db9 serial to fiber media converter and the catheter input module 1¿cm1 pin box both had water damage.There was no harm to the patient or the staff.
Additional Manufacturer Narrative
The root cause of the investigation is inconclusive since the device was not returned for analysis.Based on communication with the user the root cause of the event may be traced to liquid intrusion from a ruptured saline bag.

• Brand Name: WORKMATE CLARIS EP-4 CARDIAC STIMULATOR
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10080860
• Report Number: 2184149-2020-00055
• Device Sequence Number: 17124366
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: H403023
• Device Catalogue Number: H403023
• Device Lot Number: 5293033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDIA CONV, DB9 TO FIBER SC.; WORKMATE¿ CLARIS¿ SYSTEM CATHETER INTERFACE.; MEDIA CONV, DB9 TO FIBER SC; WORKMATE¿ CLARIS¿ SYSTEM CATHETER INTERFACE MODULE
• Outcome Attributed to Adverse Event: Other