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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PROPONENT MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L231
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Human-Device Interface Problem (2949)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2022
Event Type  Injury  
Event Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The plan is to monitor and evaluate the battery status later on in order to postpone the replacement procedure as long as possible.This device remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
Additional information was requested.The investigation will be updated should further information be provided.
 
Manufacturer Narrative
Additional information was requested.The investigation will be updated should further information be provided.
 
Event Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The plan is to monitor and evaluate the battery status every three months in order to postpone the replacement procedure as long as possible.This device remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The plan was to monitor and evaluate the battery status every three months in order to postpone the replacement procedure as long as possible.This device was replaced and returned for analysis.No additional adverse patient effects were reported.Customer comment: the physician requested the possibility to have battery details printed from the programmer as well as a shortcut on remote monitoring to view battery details.Also, requested to have an alert when high, abnormal energy drain is detected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Additional information was requested.The investigation will be updated should further information be provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Additional information was requested.The investigation will be updated should further information be provided.Follow up report 3: upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.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 the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The plan was to monitor and evaluate the battery status every three months in order to postpone the replacement procedure as long as possible.This device was replaced and returned for analysis.No additional adverse patient effects were reported.Customer comment: the physician requested the possibility to have battery details printed from the programmer as well as a shortcut on remote monitoring to view battery details.Also, requested to have an alert when high, abnormal energy drain is detected.
 
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Brand Name
PROPONENT MRI EL 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 Key14033756
MDR Text Key288788680
Report Number2124215-2022-04780
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/20/2023
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 Date11/10/2019
Device Model NumberL231
Device Catalogue NumberL231
Device Lot Number774228
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2022
Initial Date FDA Received04/06/2022
Supplement Dates Manufacturer Received04/26/2022
08/25/2023
11/30/2023
Supplement Dates FDA Received05/22/2022
09/16/2023
12/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age88 YR
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