MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L331

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problem Perforation (2001)

Event Date 01/10/2021

Event Type  Injury  

Event Description

It was reported that three days following the implant procedure of this device, the patient presented back to the hospital feeling unwell.Device data review revealed loss of capture and asystole greater than 2 seconds from the right ventricular (rv) lead.Diagnostic imaging was performed which showed the rv lead had dislodged and perforated the ventricle.Because the healthcare facility did not have appropriate electrophysiology equipment, the physician elected to disable this device and implant a temporary device pending transfer to another facility.It is unknown at this time if the rv lead is a boston scientific product.At this time, the device remains implanted but out of service.The patient was stable with no additional adverse consequences.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (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: 11355192
• MDR Text Key: 232833829
• Report Number: 2124215-2021-03583
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 884349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR