MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WI-BOX¿ WIRELESS SOLUTION

Model Number CVD0056

Device Problems Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

During a case, the connection of the wi-box with the hemodynamic system dropped out, resulting in cancellation of the procedure.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During a case, the connection of the wi-box with the hemodynamic system dropped out.The issue was isolated to a non-abbott device.The procedure was cancelled, and no further information has been provided.The procedure was rescheduled and completed the next day.The wi-box is fully functioning in the (b)(6).

• Brand Name: WI-BOX¿ WIRELESS SOLUTION
• Type of Device: WI-BOX
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16040814
• MDR Text Key: 306330590
• Report Number: 2184149-2022-00299
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CVD0056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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