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

Model Number L331

Device Problems Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)

Patient Problems Fall (1848); Head Injury (1879); Syncope/Fainting (4411)

Event Date 03/12/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room with syncope, the patient had fallen a few times and the head was hit.Device remote interrogation was performed, and loss of capture and an increase in the pacing threshold measurements were observed on the right ventricular (rv) lead.It was also noted that the rv automatic capture (rvac) feature was turned off.Additionally, this rv lead exhibited a gradual increase in pace impedance measurements since (b)(6) 2021.The lead was reprogrammed to unipolar mode and the thresholds measurements were better, and the rvac feature was turned on.At this time, this rv lead remains in service and there were no additional adverse patient effects reported.

Event Description

It was reported that the patient presented to the emergency room with syncope, the patient had fallen a few times and the head was hit.Device remote interrogation was performed, and loss of capture and an increase in the pacing threshold measurements were observed on the right ventricular (rv) lead.It was also noted that the rv automatic capture (rvac) feature was turned off.Additionally, this rv lead exhibited a gradual increase in pace impedance measurements since august 2021.The lead was reprogrammed to unipolar mode and the thresholds measurements were better, and the rvac feature was turned on.At this time, this rv lead remains in service and there were no additional adverse patient effects reported.Currently, this pacemaker was explanted and replaced.The pacemaker has been received for analysis.

Manufacturer Narrative

Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem.B2: outcome attributed to adverse event.B5: describe event or problem field.D6b: explant date.H1: type of reportable event.H6: impact codes.Additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the pacemaker was analyzed and passed all returned product testing, and with no further information to indicate a product performance issue, it was concluded proper operation of the pacing, sensing, and shocking functions of the device.Additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that the patient presented to the emergency room with syncope, the patient had fallen a few times and the head was hit.Device remote interrogation was performed, and loss of capture and an increase in the pacing threshold measurements were observed on the right ventricular (rv) lead.It was also noted that the rv automatic capture (rvac) feature was turned off.Additionally, this rv lead exhibited a gradual increase in pace impedance measurements since (b)(6) 2021.The lead was reprogrammed to unipolar mode and the thresholds measurements were better, and the rvac feature was turned on.At this time, this rv lead remains in service and there were no additional adverse patient effects reported.Currently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.

• 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: 14023628
• MDR Text Key: 288686911
• Report Number: 2124215-2022-09471
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2022

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: 11/23/2020
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 817513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 03/16/2022; 04/18/2022
• Supplement Dates FDA Received: 04/09/2022; 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• 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: 81 YR
• Patient Sex: Male