MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3501

Device Problems Fracture (1260); Failure to Sense (1559); Impedance Problem (2950)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this electrode exhibited no sensing and out of range shock impedance measurements.The electrode was observed to be fractured about 12 to 15 centimeters (cm) from the device header where it was curled or crimped.Surgical intervention was undertaken.The electrode was explanted.The patient was implanted with a transvenous implantable cardioverter defibrillator (icd) system.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this electrode was thoroughly inspected and analyzed.Visual examination confirmed a complete fracture of the electrode (conductor and insulation) 14.5 centimeters (cm) from the terminal end.Patient code of 3191 used to capture the reportable event of surgery.

Event Description

Analysis of this device was completed.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this electrode was thoroughly inspected and analyzed.Visual examination confirmed a complete fracture of the electrode (conductor and insulation) 14.5 centimeters (cm) from the terminal end.

Event Description

It was reported that analysis of this product was completed.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this electrode was thoroughly inspected and analyzed.Visual examination confirmed a complete fracture of the electrode (conductor and insulation) 14.5 centimeters (cm) from the terminal end.

Event Description

It was reported that this electrode exhibited no sensing and out of range shock impedance measurements.The electrode was observed to be fractured about 12 to 15 centimeters (cm) from the device header where it was curled or crimped.Surgical intervention was undertaken.The electrode was explanted.The patient was implanted with a transvenous implantable cardioverter defibrillator (icd) system.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The product has been received for analysis.This report will be updated upon completion of analysis.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10681523
• MDR Text Key: 211436621
• Report Number: 2124215-2020-19066
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 123222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 12/17/2020; 01/29/2021; 08/13/2021
• Supplement Dates FDA Received: 01/16/2021; 02/25/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR