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

Model Number L311

Device Problems Failure to Capture (1081); Failure to Read Input Signal (1581); Unexpected Therapeutic Results (1631)

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

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.As such, physical analysis has not been conducted in our laboratory.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker device exhibited, increasing threshold measurements for unknown reason resulting in loss of capture.No reports of adverse patient impact.The physician reported, the device reprogrammed was required to increase thresholds and reestablish capture for the dependent patient.Additional information was received.A technical service (ts) consultant reviewed device data from home monitor.Advised to have patient return to the office, for additional testing, under bipolar and unipolar settings.The device remains implanted.No adverse patient effects were reported.

• Brand Name: ACCOLADE MRI 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: 15655977
• MDR Text Key: 302247447
• Report Number: 2124215-2022-42911
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2023
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 571985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1