MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. RECORDCONNECT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700090

Device Problems Failure to Analyze Signal (1539); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

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 the procedure, the record connect would not display signals and the procedure was cancelled.No intracardiac signals would display on the recording system but displayed on the mapping system.The right limb lead was replaced several times with no resolution.The record connect was bypassed and the signals displayed for 30 seconds but disappeared on the mapping system.After manipulating the record connect and adjusting the connections in the pinbox, all signals were lost.The procedure was rescheduled.Further troubleshooting identified incompatible ekg cables that connected to the record connect.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

One record connect was received for investigation.All input and output connectors were free of physical damage and connector cabling was free of nicks, cuts and abrasions.No noise or signal distortion was noted.Based on the information provided to abbott and the investigation performed, the root cause of the reported signal issue and subsequent procedure cancellation was due to incompatible ekg cables.

• Brand Name: RECORDCONNECT
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9744092
• MDR Text Key: 189886181
• Report Number: 2184149-2020-00026
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K132073
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other