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

Model Number E162

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 07/15/2020

Event Type  Injury  

Event Description

It was reported that this patient was performing strenuous physical activity and experienced ventricular arrhythmias resulting in palpitations.Boston scientific technical services were contacted where it was discussed the programmed ventricular pacing rate of the device initially induced ventricular tachycardia (vt).Anti-tachycardia pacing (atp) and 41j shocks were appropriately delivered; however the rhythm shortly afterwards accelerated into ventricular fibrillation (vf).The vf was eventually successfully terminated with a shock.Technical services were contacted and provided programming recommendations to resolve the event.The physician elected to continue with remote monitoring.The patient was stable with no additional adverse consequences reported.The device remains implanted and in service.

• 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: 10618050
• MDR Text Key: 209553982
• Report Number: 2124215-2020-15614
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: 00802526480775
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2015
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 106246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR