MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problems Twiddlers Syndrome (2114); Electric Shock (2554); No Code Available (3191); Twiddlers Syndrome (4563)

Event Date 12/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient received an inappropriate shock involving this device.The patient was going to be hospitalized to perform an x-ray.A review of the device data by engineering noted that low out of range shock impedance measurements were seen, and the day after the shock was delivered due to non physiological signal oversensing likely due to twiddlers syndrome, a charge timeout error was seen.The patient should be considered unprotected, and alternate therapy should be arranged prior to an urgent device replacement.It was not possible to determine the cause of the charge timeouts and low impedance measurements.The device was subsequently explanted and will be returned.No additional adverse patient effects were reported.

Event Description

It was reported that this patient received an inappropriate shock involving this device.The patient was going to be hospitalized to perform an x-ray.A review of the device data by engineering noted that low out of range shock impedance measurements were seen, and the day after the shock was delivered due to non physiological signal oversensing likely due to twiddlers syndrome, a charge timeout error was seen.The patient should be considered unprotected, and alternate therapy should be arranged prior to an urgent device replacement.It was not possible to determine the cause of the charge timeouts and low impedance measurements.The device was subsequently explanted and returned.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, analysis confirmed no telemetry and an odd sequence of tones was heard when a magnet was applied.The device case was opened and became hot during the case removal process.The battery assembly was isolated, and testing found electrical overstress damage to the high voltage capacitor.Laboratory analysis noted that the cause of the no telemetry condition and odd beeping sequence was electrical overstress damage to the device, while the cause of the electrical overstress was unknown.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 11105322
• MDR Text Key: 224746489
• Report Number: 2124215-2020-26747
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2022

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: 09/23/2022
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 130994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female