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

Model Number G447

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)

Patient Problems Electric Shock (2554); Twiddlers Syndrome (4563)

Event Date 05/08/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing on the right ventricular channel.Due to this, the device delivered inappropriately eight shocks, the therapy got exhausted.It was determined that this was due to the lead having dislodged and the device having migrated.This was cause due to the patient experiencing twiddlers syndrome.The therapy was turned off and an external defibrillator was provided to the patient.A revision of the system was scheduled for the near future.At this time, this device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field d6b: explant date h1: type of reportable event h6: impact codes.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing on the right ventricular channel.Due to this, the device delivered inappropriately eight shocks, the therapy got exhausted.It was determined that this was due to the lead having dislodged and the device having migrated.This was cause due to the patient experiencing twiddlers syndrome.The therapy was turned off and an external defibrillator was provided to the patient.A revision of the system was scheduled for the near future.At this time, this device remains in service.No further adverse patient effects were reported.Additional information was received detailing that x-rays were performed in order to confirm the twiddlers syndrome.The system revision was performed and this device was explanted and replaced.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: IMPLANTABLE DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17018519
• MDR Text Key: 316095180
• Report Number: 2124215-2023-26988
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 296927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female