MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND RESONATE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number G447

Device Problem Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Engineering review of the device memory confirmed there were no resets or faults recorded.The x-ray showed no evidence of a connection issue.The cause of the noise was most likely air escaping the header.The device and lead remain in service.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that during the implant procedure for this cardiac resynchronization therapy defibrillator (crt-d), noise was observed on the right ventricular (rv) lead.The terminal pin was removed and reconnected to the device and this appeared to resolve the noise.The pocket was closed to complete the procedure, then noise was again observed on the rv lead.Device data was submitted to technical services for review.The noise was suspected to be air escaping the device header.The following day, extensive testing and troubleshooting was performed; while patient maneuvers, postures, and movements were performed no noise was created and pacing impedance measurements remained stable.An x-ray was planned before the patient was discharged.Also, the patient will be followed on the remote monitoring system.No adverse patient effects were reported.

• Brand Name: RESONATE
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7619528
• MDR Text Key: 111677596
• Report Number: 2124215-2018-09445
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2020
• Device Model Number: G447
• Other Device ID Number: RESONATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0283; 4671; 7736; G447
• Patient Age: 67 YR