MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE LEAD

Model Number L310

Device Problem Premature Discharge of Battery (1057)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this device declared code 1003 indicative of voltage too low to project the remaining longevity before it was implanted.As result the device could not be implanted.The information was sent to boston scientific technical services (ts) to be analyzed.No patient involvement.

Event Description

This device recorded a pre-implant 1003 code indicative of battery voltage too low for the projected remaining capacity.There is no patient involvement at the time of this issue; therefore, there is no risk of serious injury, compromised critical therapy or death.Trend inclusion has no impact on the reporting decision.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.An evaluation of the device was performed.Review of the device memory 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.

Event Description

It was reported that this device recorded a pre-implant 1003 code indicative of battery voltage too low for the projected remaining capacity.The device voltage tracks being exposed to cold temperatures, however, no information was received that it was recovered for implant.There is no patient involvement at the time of this issue.

• Brand Name: ACCOLADE MRI SR
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11182966
• MDR Text Key: 227561649
• Report Number: 2124215-2020-27681
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559204
• UDI-Public: 00802526559204
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: L310
• Device Catalogue Number: L310
• Device Lot Number: 813357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 03/15/2021
• Patient Sequence Number: 1