MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. RECORDCONNECT; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number 100051780

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During a supraventricular tachycardia procedure, no ekg signal was observed on the mapping system and the case was cancelled.The system reference was connected to the navlink and all connections appeared correct.However, the issue was not solved and the case was cancelled with no consequences to the patient.The procedure was completed with a new recordconnect the following day.

Manufacturer Narrative

Additional information: one recordconnect was received for analysis.Visual inspection of the returned product indicated signs of wear that is consistent with clinical usage.All input and output connectors were free of physical damage and the connector cabling is free of nicks, cuts and abrasions.Functional testing was completed successfully without error; no noise or signal distortion was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of reported signal issue and subsequent cancellation could not be conclusively determined.

• Brand Name: RECORDCONNECT
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8851413
• MDR Text Key: 152957500
• Report Number: 2184149-2019-00144
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100051780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other