MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	L221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Fever (1858)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the patient with this device presented with a fever.The patient was hospitalized and diagnosed by trans-esophageal echocardiogram, with bacterial endocarditis.The physician stated the system required explant however, no information was provided regarding the system lead manufacture and the device was later reported as explanted.Following antibiotic treatment and a normal echocardiogram, a new bicameral pacemaker implant will be scheduled.No allegations against the boston scientific product were made.

• 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 Key: 8720339
• Report Number: 2124215-2019-11400
• Device Sequence Number: 1684959
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: Health Professional
• Device Expiration Date: 04/13/2018
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 712304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 79 YR