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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PROPONENT EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L221
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Erosion (1750); Unspecified Infection (1930); No Code Available (3191)
Date of Event 07/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient implanted with this pacemaker presented with erosion/extrusion of the device.Infection was likely but not confirmed.The pacemaker and non-boston scientific leads were explanted and a new system was implanted on the patient's right side.No additional adverse patient effects were reported.
 
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Brand Name
PROPONENT EL 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 Key10775447
Report Number2124215-2020-23257
Device Sequence Number1074578
Product Code LWP
UDI-Device Identifier00802526559112
UDI-Public00802526559112
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
N970003/S167
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/02/2020
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? No
Operator of Device Lay User/Patient
Device Expiration Date03/02/2019
Device Model NumberL221
Device Catalogue NumberL221
Device Lot Number719508
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/23/2020
Initial Report FDA Received Date11/02/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age51 YR
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