MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	M00420020340
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the recording system froze and was the only device in use to monitor heart rhythm.A lab system pro ep recording system and a cryoablation catheter were selected for use during a para-hisian kent ablation procedure.Ablation progress was being monitored by reading endocardial signals.The lab system pro was the only device in use to monitor heart rhythm.The physician was ablating when the screen froze; the screen was no longer transmitting information in real time.During this time, the physician was unable to see changes in rhythm.No error messages popped up.The freeze lasted 10 seconds.The freeze was resolved by pressing the f8 button several times to create a new event.When the signals finally updated, the physician saw atrioventricular (av) block; therefore, he stopped ablating and the av block disappeared.It was unknown how long the av block lasted, as it began when the screen was frozen.The av block was transient and did not require intervention.

• Brand Name: LABSYSTEM PRO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 7864907
• Report Number: 2134265-2018-60904
• Device Sequence Number: 13787417
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: M00420020340
• Device Catalogue Number: 86623
• Device Lot Number: 0001955176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1