MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE

Model Number A219

Device Problems No Audible Alarm (1019); High impedance (1291); Failure to Sense (1559); Defective Device (2588); Battery Problem (2885); Interrogation Problem (4017)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported that during an implantation procedure, the subcutaneous implantable cardioverter defibrillator (s-icd) system was an attempted implant due to the s-icd being damaged or defective.Subsequently, an new s-icd system was successfully implanted.No adverse patient effects were reported.

Event Description

It was reported that during an implantation procedure, the subcutaneous implantable cardioverter defibrillator (s-icd) system was an attempted implant due to the s-icd being damaged or defective.Subsequently, an new s-icd system was successfully implanted.No adverse patient effects were reported.Additional information was received indicating that during the procedure, the pulse generator would not interrogate and there were tones could not be elicited.When the device eventually connected, there was no sensing signal.High, out-of-range shock impedance measurements of greater than 400 ohms were also observed.Eventually, they realized the programmer was connecting to a spare device in the case cart, and the attempted s-icd was dead.Subsequently, the new s-icd system was implanted.No adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 18370989
• MDR Text Key: 331050502
• Report Number: 2124215-2023-72859
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 170573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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 Age: 21 YR
• Patient Sex: Male