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

Model Number L331

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

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

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that this implantable pacemaker was suspected of premature battery depletion (pbd).Additional information indicated that this device longevity dropped from 5 years to 11 months in a span of 6 months.Data analysis showed that the device power consumption is high and changing in an unpredictable manner without cause.Normal device operation cannot be assured, prompt replacement is recommended.To date, this device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable pacemaker was suspected of premature battery depletion (pbd).Additional information indicated that this device longevity dropped from 5 years to 11 months in a span of 6 months.Data analysis showed that the device power consumption is high and changing in an unpredictable manner without cause.Normal device operation cannot be assured, prompt replacement is recommended.To date, this device remains in service.Additional information indicated that this device was explanted and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

This supplemental correction report was created to capture updates on h1: type of reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable pacemaker was suspected of premature battery depletion (pbd).Additional information indicated that this device longevity dropped from 5 years to 11 months in a span of 6 months.Data analysis showed that the device power consumption is high and changing in an unpredictable manner without cause.Normal device operation cannot be assured, prompt replacement is recommended.To date, this device remains in service.Additional information indicated that this device was explanted and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE 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: 18914513
• MDR Text Key: 337788105
• Report Number: 2124215-2024-15902
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024

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: 11/17/2019
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 775200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 05/01/2024; 05/01/2024
• Supplement Dates FDA Received: 05/03/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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 Age: 70 YR