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

Model Number E162

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 09/18/2022

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriately a shock due to atrial fibrillation with rapid ventricular response.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that the device entered in safety mode and is planned to be replaced in the near future.

• Brand Name: INCEPTA ICD
• Type of Device: IMPLANTABLE 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: 15801531
• MDR Text Key: 303748982
• Report Number: 2124215-2022-47298
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: 00802526480775
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2013
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 101513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2012
• 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 Age: 77 YR
• Patient Sex: Female