MAUDE Adverse Event Report: BOSTON SCIENTIFIC RHYTHMIA MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Lot Number 111115

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Event Description

The patient was prepared for an atrial fib ablation.Upon testing the patch system prior to the procedure, an elevated impedance was noted and the patch was changed.The procedure proceeded with no further problems noted.There was no patient harm noted.

• Brand Name: RHYTHMIA MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5797764
• MDR Text Key: 49633376
• Report Number: 5797764
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2016,06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 111115
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR