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

Model Number 87038

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2022

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.

Event Description

Post ablation procedure a rhythmia hdx mapping system was selected for use.The physician noticed interference after ablation was completed, and the procedure was ultimately not completed due to the incident.The patient is currently in good condition.

• 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: 14435871
• MDR Text Key: 292047455
• Report Number: 2134265-2022-05663
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729938712
• UDI-Public: 08714729938712
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 87038
• Device Catalogue Number: 87038
• Device Lot Number: S0000906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1