MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEVICE

Model Number G447

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Failure to Select Signal (1582); Low impedance (2285)

Patient Problem Twiddlers Syndrome (2114)

Event Date 02/16/2019

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that this device, right atrial (ra), right ventricular (rv) and left ventricular (lv) lead exhibited noise and decreased amplitude measurements.Some of the noise on the ra channel appeared to be consistent with oversensing related to the minute ventilation feature and high out of range ra pacing impedance measurements greater than 2,000 ohms was observed.Additionally, decreased pacing impedance measurements and loss of capture (loc) was observed on the rv channel.It was reported that the patient suffered from twiddlers syndrome and appeared to have twiddled the system.The ra lead was suspected to have fractured as a result.An invasive procedure was performed.The product was part of a system explant.Available information indicates that no new system was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

This supplemental report is being filed to update the evaluation conclusion code.

Event Description

It was reported that the product is in possession of the hospital.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8510751
• MDR Text Key: 141808184
• Report Number: 2124215-2019-06275
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2020
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 191874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 06/05/2019
• Supplement Dates FDA Received: 04/20/2019; 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR