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

Model Number L311

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that this device was suspected of exhibiting premature battery depletion behavior.It was noted that the patient has atrial flutter.The device was programmed to a dual chamber (dddr) mode to pace and sense both the atrium and the ventricle.The patient was almost 100% right ventricular paced.The rv auto output was set to auto capture @ 5.0v @ 0.4ms and the battery had 5 months remaining.The pacemaker was adjusted to a single chamber mode (vvir) with a fixed rv output, only increasing the battery longevity to 7 months.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.This device is expected for return.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this device was suspected of exhibiting premature battery depletion behavior.It was noted that the patient has atrial flutter.The device was programmed to a dual chamber (dddr) mode to pace and sense both the atrium and the ventricle.The patient was almost 100% right ventricular paced.The rv auto output was set to auto capture @ 5.0v @ 0.4ms and the battery had 5 months remaining.The pacemaker was adjusted to a single chamber mode (vvir) with a fixed rv output, only increasing the battery longevity to 7 months.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.This device is expected for return.This device was not returned for analysis.Despite several requests to obtain product return, no further information was provided.

• 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: 18923984
• MDR Text Key: 337903800
• Report Number: 2124215-2024-16186
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150012/S000
• 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
• Report Date: 03/18/2024

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 Expiration Date: 04/20/2019
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 290954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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): Required Intervention; Hospitalization
• Patient Sex: Male