MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE DEVICE

Model Number L331

Device Problems Failure to Capture (1081); Failure to Read Input Signal (1581); Connection Problem (2900); High Capture Threshold (3266)

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

Event Date 02/16/2024

Event Type  Injury  

Event Description

It was reported that this patient was implanted with a pacemaker system.One day post operative, the field representative went to perform a pre-discharge check and noted right atrial (ra) and right ventricular (rv) thresholds were higher than at implant.Impedance and amplitudes were within range.The device was programmed to unipolar, and thresholds were checked again and this time there was loss of capture on both leads.A chest x-ray was performed and there was suspected lead migration/dislodgement and perforation for both leads.The physician decided to perform a lead extraction and use passive fixed leads.A lead revision procedure was performed, and the leads were removed.When they connected the new leads to the device there was a drop in r wave amplitudes therefore, the rv lead was re-positioned.This time they had good measurements from the pacing system analyzer (psa) and from the device, so they began closing the pocket.On the sub-q layer of sutures, there was an increase instance of failed av search so lead tests were ran again.It was noted there was an acute rise in rv thresholds in bipolar and again loss of capture in unipolar.The device was removed from the pocket, and they tested ra and rv thresholds using the psa and they were acceptable measurements.The leads were plugged back in the original device used from implant and there were normal measurements in bipolar however, abnormal measurements when in unipolar.The ra had loss of capture and rv had high thresholds.Subsequently, the device was removed, and a new device was implanted.Lead testing was performed, and all lead measurements were within range.At pre-discharge they confirmed again all measurements were normal when programmed in bipolar and unipolar.

• Brand Name: ACCOLADE MRI EL DR
• 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: 18808176
• MDR Text Key: 336568342
• Report Number: 2124215-2024-12245
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

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 Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 646901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 02/29/2024
• Date Device Manufactured: 01/22/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female