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

Model Number	H701374
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with the investigation results will be provided in a subsequent submission.
Event or Problem Description
During a procedure, the image was poor when the ice catheter was in use.Different catheters were used but the issue remained.As no replacement catheter interface module (cim) was available, the procedure was cancelled.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: 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.Based on the information received, the cause of the reported incident could not be 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: 8683609
• Report Number: 2184149-2019-00107
• Device Sequence Number: 2232252
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K120703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 4947892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 93