MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) LABSYSTEM¿ PRO EP RECORDING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M0042002029R0

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mfr id # 2134265-2017-11941.It was reported that incorrect pacing occurred.It was reported that during an electrophysiology procedure involving an lspro and a non-bsc simulator, pacing was delivered to the atrium; however, pacing was also delivered to the ventricle though a secondary catheter located in the ventricle.The physician was only able to resolve the secondary pacing by physically unplugging the catheter that was located in the ventricle in order to only pace the atrium.It was suspected that the cable may have been internally damaged; however no visual damage was observed.No patient complications reported.

• Brand Name: LABSYSTEM¿ PRO EP RECORDING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7050787
• MDR Text Key: 93208190
• Report Number: 2134265-2017-11977
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/24/2017

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: M0042002029R0
• Device Catalogue Number: 2002029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1