MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L211

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problems Syncope (1610); Fall (1848); Syncope/Fainting (4411)

Event Date 12/29/2020

Event Type  Injury  

Event Description

It was reported that this patient experienced a collapse after an episode of dizziness and presented to the hospital.Upon device data review, over-sensed noise from the competitor's right ventricular (rv) lead was noted.This over-sensing resulted in pacing inhibition and was reproducible with provocative maneuvers.It was noted the physician elected to not perform a rv revision procedure and elected to reprogram the device sensitivity.Diagnostic imaging was also performed.Boston scientific technical services was contacted and recommended close remote monitoring if a rv lead revision is not performed.At this time, the system remains implanted and in-service.Additional information has been requested regarding healthcare facility information, but has not yet been received.No additional adverse patient effects were reported.

Manufacturer Narrative

With all the available information, bsc is unable to conclude the root cause of the incident.This device has not been returned; therefore, a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient experienced a collapse after an episode of dizziness and presented to the hospital.Upon device data review, over-sensed noise from the competitor's right ventricular (rv) lead was noted.This over-sensing resulted in pacing inhibition and was reproducible with provocative maneuvers.It was noted the physician elected to not perform a rv revision procedure and elected to reprogram the device sensitivity.Diagnostic imaging was also performed and no physical damage was noted.Boston scientific technical services was contacted and recommended close remote monitoring if a rv lead revision is not performed.The physician elected to continue with close monitoring and at this time, the system remains implanted and in-service.No additional adverse patient effects were reported.

• Brand Name: PROPONENT MRI DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11233716
• MDR Text Key: 228830384
• Report Number: 2124215-2021-02219
• Device Sequence Number: 1
• Product Code: LWP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/12/2022
• Device Model Number: L211
• Device Catalogue Number: L211
• Device Lot Number: 504993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention