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

Model Number L310

Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this device was explanted after 8 months of being implanted.The non-bsc right ventricular (rv) lead was surgically abandoned.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that this device was explanted after 8 months of being implanted.During the rv lead revision the pacemaker was accidentally touched by one of the nurses that was not scrubbed into the case, thus rendering it unsterile.Non-bsc right ventricular (rv) lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE MRI SR
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11206841
• MDR Text Key: 227918030
• Report Number: 2124215-2021-00965
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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: 12/06/2021
• Device Model Number: L310
• Device Catalogue Number: L310
• Device Lot Number: 804109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR