MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWMATE¿ Z CATHETER INTERFACE MODULE; SYSTEM, SIGNAL ISOLATION

Model Number	H701374
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
During a cryo atrial fibrillation procedure, a rattling noise was heard within the cim and the unit displayed dark images so the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The cim was replaced in the field and the customer retained the unit so it will not be returned.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 received, the cause of the reported display issue and subsequent procedure cancellation could not be conclusively determined.

• Brand Name: VIEWMATE¿ Z CATHETER INTERFACE MODULE
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9530630
• Report Number: 2184149-2019-00257
• Device Sequence Number: 16838562
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 5074241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other