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

Model Number L311

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested.This investigation will be updated should further information be provided.

Event Description

It was reported that this pacemaker recorded a code 1003, which is indicative of battery voltage too low for the projected remaining capacity, during a pre-implant interrogation, possibly triggered due to cold weather.The device data has not been analyzed and cleared for implant.No patient involvement.

Manufacturer Narrative

The conclusion code was selected based on lack of objective evidence of a device malfunction and passing product record reviews.The product has not been returned for analysis.

Event Description

It was reported that this pacemaker recorded a code 1003, which is indicative of battery voltage too low for the projected remaining capacity, during a pre-implant interrogation.Engineering analysis confirmed the code 1003 was triggered due to cold weather.There were no other concerning codes or resets.It was determined the pacemaker is operating normally and was cleared for implant.No patient involvement.

Manufacturer Narrative

Review of the device data confirmed that a low voltage alert, code 1003, was recorded and that the device recorded low temperature readings prior to setting the low voltage alert.If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.This appears to be the case with this device.The battery did recover after the device was removed from the cold.

Event Description

It was reported that this pacemaker recorded a code 1003, which is indicative of battery voltage too low for the projected remaining capacity, during a pre-implant interrogation.Engineering analysis confirmed the code 1003 was triggered due to cold weather.There were no other concerning codes or resets.It was determined the pacemaker is operating normally and was cleared for implant.No patient involvement.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11227991
• MDR Text Key: 258613803
• Report Number: 2124215-2021-01947
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

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: Other
• Device Expiration Date: 05/16/2021
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 427486
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 02/20/2021; 04/26/2021
• Supplement Dates FDA Received: 02/25/2021; 06/29/2021
• Patient Sequence Number: 1