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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PROPONENT DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L201
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This device was discarded at the facility and will not be returned for analysis.As no further information concerning this report is expected our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this device was exhibiting behavior consistent with premature battery depletion (pbd).The device was explanted, and a new device implanted.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated.
 
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Brand Name
PROPONENT DR
Common Device Name
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9995430
Report Number2124215-2020-08972
Device Sequence Number4203287
Product Code LWP
UDI-Device Identifier00802526559044
UDI-Public00802526559044
Combination Product (Y/N)N
Initial Reporter CountryQA
PMA/510(K) Number
N970003/S167
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/24/2020
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
Operator of Device Lay User/Patient
Device Expiration Date08/25/2018
Device Model NumberL201
Device Catalogue NumberL201
Device Lot Number746268
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/22/2020
Initial Report FDA Received Date04/24/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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