MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number E143

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Arrhythmia (1721)

Event Date 11/19/2022

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) showed a ventricular tachycardia (vt) event with therapies.During the vt episode, there was blanking period under sensing and possible right ventricular pace on t wave, which precedes the vt event, and possibly provokes it.Anti-tachycardia pacing attempts fail, but an electric shock converts the rhythm.It was recommended to reprogram the icd around rv blanking settings.The icd remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: ENERGEN ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 15958319
• MDR Text Key: 305241942
• Report Number: 2124215-2022-51926
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: 00802526480744
• 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: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2016
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 113229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Male