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

Model Number E162

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

Patient Problem Pocket Erosion (2013)

Event Date 12/16/2022

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.There were no additional adverse patient effects reported.The icd was explanted.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INCEPTA 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16022527
• MDR Text Key: 305886400
• Report Number: 2124215-2022-54058
• Device Sequence Number: 1
• Product Code: LWP
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2016
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 112934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2014
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male