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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PROPONENT MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L211
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2023
Event Type  malfunction  
Event Description
It was reported that abnormal signals were recorded by this pacemaker on the right atrial (ra) electrogram (egm).Of note, this dual-chamber pacemaker is being used as an atrial-pacing atrial-sensing inhibited-response rate-adaptive (aair) system with a plugged right ventricular (rv) port (no rv lead in place).Therefore, there are no events, but this is due to the fact that a dr pacemaker is being used as an aai.A boston scientific rhythmcare support specialist reminded the health care professional (hcp) that failure to connect a functional rv lead is officially considered off-label use.It was also mentioned that this makes diagnosing an atrial lead defect difficult in the absence of atrial tachy response (atr) episode storage or ventricular tachycardia (vt) episodes.It is unclear if the abnormal signal on the ra egm is a potential loss of capture or atrial extrasystoles, and it is possible this signal is sometimes sensed by the pacemaker.Ra lead troubleshooting was advised.Of note, the ra lead is a non-boston scientific product.No adverse patient effects were reported.This system remains in service.
 
Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
 
Event Description
It was reported that abnormal signals were recorded by this pacemaker on the right atrial (ra) electrogram (egm).Of note, this dual-chamber pacemaker is being used as an atrial-pacing atrial-sensing inhibited-response rate-adaptive (aair) system with a plugged right ventricular (rv) port (no rv lead in place).Therefore, there are no events, but this is due to the fact that a dr pacemaker is being used as an aai.A boston scientific rhythmcare support specialist reminded the health care professional (hcp) that failure to connect a functional rv lead is officially considered off-label use.It was also mentioned that this makes diagnosing an atrial lead defect difficult in the absence of atrial tachy response (atr) episode storage or ventricular tachycardia (vt) episodes.It is unclear if the abnormal signal on the ra egm is a potential loss of capture or atrial extrasystoles, and it is possible this signal is sometimes sensed by the pacemaker.Ra lead troubleshooting was advised.Of note, the ra lead is a non-boston scientific product.No adverse patient effects were reported.This system remains in service.
 
Manufacturer Narrative
The "intentional off-label use" conclusion code was selected based on information in the complaint.The complaint device was not returned to boston scientific for analysis (the product remains implanted), and product record reviews did not identify a product quality issue or new patient harm.
 
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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
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 Key18460534
MDR Text Key332602575
Report Number2124215-2024-00513
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberL211
Device Catalogue NumberL211
Device Lot Number644098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age51 YR
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