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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT MRI SR; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION PROPONENT MRI SR; IMPLANTABLE DEVICE Back to Search Results
Model Number L210
Device Problems No Audible Alarm (1019); Premature Discharge of Battery (1057); Telemetry Discrepancy (1629)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
Event Type  Injury  
Event Description
It was reported that this pacemaker was unable to be interrogated nor have a response to magnet application.The cause is attributed to suspected battery depletion.Currently, this device remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this pacemaker was unable to be interrogated nor have a response to magnet application.The cause is attributed to suspected battery depletion.This device was explanted and returned for analysis.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.
 
Event Description
It was reported that this pacemaker was unable to be interrogated nor have a response to magnet application.The cause is attributed to suspected battery depletion.This device was explanted and returned for analysis.No additional adverse patient effects were reported.
 
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Brand Name
PROPONENT MRI SR
Type of Device
IMPLANTABLE DEVICE
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 Key14048454
MDR Text Key288885777
Report Number2124215-2022-05260
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/17/2017
Device Model NumberL210
Device Catalogue NumberL210
Device Lot Number708115
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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