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

Model Number L301

Device Problems Failure to Capture (1081); High impedance (1291); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problems Fall (1848); Syncope/Fainting (4411)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that this system with a pacemaker and a non-bsc right ventricular (rv) lead showed high, pacing impedance values when interrogated after syncopal events the patient experienced.Spring contact issues were discussed as impedances appear unstable.Failure to capture was observed on telemetry when the syncope appears to have occurred.The patient appears to have fallen but luckily did not break her hip.It appears that automatic threshold tests have been failing recurrently as the tests take place in great numbers.Reprogramming options were recommended, and the device has already been reprogrammed around pace/sense polarity, which is the recommended change when spring issues are suspected.The pacemaker and the rv lead remain in service.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 system with a pacemaker and a non-bsc right ventricular (rv) lead showed high, pacing impedance values when interrogated after syncopal events the patient experienced.Spring contact issues were discussed as impedances appear unstable.Failure to capture was observed on telemetry when the syncope appears to have occurred.The patient appears to have fallen but luckily did not break her hip.It appears that automatic threshold tests have been failing recurrently as the tests take place in great numbers.Reprogramming options were recommended, and the device has already been reprogrammed around pace/sense polarity, which is the recommended change when spring issues are suspected.The pacemaker and the rv lead remain in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: ACCOLADE 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: 15742044
• MDR Text Key: 303141537
• Report Number: 2124215-2022-45585
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2019
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 757816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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): Other
• Patient Age: 93 YR
• Patient Sex: Female