MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	4712
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/17/2020
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 following pocket closure at an subcutaneous implantable cardioverter defibrillator (s-icd) implant a lateral x-ray was performed which showed the electrode had inadvertently been implanted in the lower side of the sternum.It was believed that the tunneling tool had been slightly near the ensiform cartilage when the electrode was being positioned.The electrode was successfully repositioned with no additional adverse patient effects reported.

• Brand Name: EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10805783
• Report Number: 2124215-2020-23867
• Device Sequence Number: 19114712
• Product Code: LWS
• UDI-Device Identifier: 00802526591907
• UDI-Public: 00802526591907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110042/S102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: 4712
• Device Catalogue Number: 4712
• Device Lot Number: 25289657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR