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

Model Number	L221
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Connection Problem (2900); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting an is-1 lead into the header of this device resulting in the over sensed noise.Please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this pacemaker detected high out-of-range right ventricular (rv) lead impedance measurements and evidence of oversensed noise.Isometrics were successful in re-creating the noise.An x-ray confirmed an under inserted lead.Surgical intervention was performed to resolve the connection issue.No adverse patient effects were reported.The device remains implanted and in service.

• 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: 9193409
• Report Number: 2124215-2019-20993
• Device Sequence Number: 14103278
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/05/2019
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 718643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR