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

Model Number L331

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Communication or Transmission Problem (2896)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that the patient with this pacemaker stated their communicator displayed an invalid radiofrequency (rf) overuse condition message.The patient stated the communicator was placed under the bed and that she uses a cpap machine which is placed near the communicator.Boston scientific technical services (ts) advised the patient not to have the cpap and communicator close together.Additionally, the battery of this device was suspected to be depleting prematurely as it decreased from 10 years to 8 years in a 3 months time period.Ts also noticed numerous rythmiq episodes.Options for optimizing programming were discussed.No adverse patient effects were reported.At this time, this device remains in service.

Event Description

It was reported that the patient with this pacemaker stated their communicator displayed an invalid radiofrequency (rf) overuse condition message.The patient stated the communicator was placed under the bed and that she uses a cpap machine which is placed near the communicator.Boston scientific technical services (ts) advised the patient not to have the cpap and communicator close together.Additionally, the battery of this device was suspected to be depleting prematurely as it decreased from 10 years to 8 years in a 3 months time period.Ts also noticed numerous rythmiq episodes.Options for optimizing programming were discussed.Further information was provided that longevity changes were observed with this device due to radiofrequency overuse.No adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: PACEMAKER
• 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: 18832905
• MDR Text Key: 336987455
• Report Number: 2124215-2024-13155
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2019
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 766207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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 Age: 77 YR
• Patient Sex: Female