MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN ICD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number E140

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Staphylococcus Aureus (2058); Seizures (2063)

Event Date 03/09/2019

Event Type  Injury  

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 Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) was part of a system that was involved in an infection issue.Reportedly, the patient came to the hospital after having a seizure that was felt to be due to having a staphylococcus infection that was confirmed via blood cultures.There were no additional adverse patient effects reported.The icd remains in service.

• Brand Name: ENERGEN ICD
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8581757
• MDR Text Key: 144091970
• Report Number: 2124215-2019-08996
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: 00802526480713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2016
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 117401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 53