MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDX; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 87042

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that due to a device issue the procedure was cancelled.During a procedure an backpatch was selected for use.When the patient was removed from the procedure table there was no tracking of the catheter on the rhythmia system.The rhythmia mapping specialist (rms) rebooted the workstation and signal station which did not resolve the issue.Replacing the cable and the catheter also did not resolve the issue.Therefore the ablation portion of the procedure was cancelled and the physician proceeded to implant the cardiac resynchronization therapy device in the patient successfully without any patient complications.Additional information revealed that after the case the rms replaced the backpatch and the problem was resolved.

• Brand Name: RHYTHMIA HDX
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10747612
• MDR Text Key: 213425666
• Report Number: 2134265-2020-14914
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729938682
• UDI-Public: 08714729938682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87042
• Device Catalogue Number: 87042
• Device Lot Number: 1000001098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1