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

Model Number E162

Device Problem Premature Discharge of Battery (1057)

Patient Problems Chest Pain (1776); Heart Failure (2206); No Code Available (3191)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product is not expected to be returned.If the product is returned, analysis would be performed, and this report would be updated at that time.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 message indicative that the battery voltage is too low for the projected remaining capacity.The battery appeared to be depleted.The patient was hospitalized suffering heart failure, and chest pain as he was having difficulty getting basic functions from this device.This device was surgically explanted and replaced, it is not expected that this product returns for analysis.No additional adverse patient effects were reported.

• Brand Name: INCEPTA ICD
• Type of Device: IMPLANTABLE PULSE GENERATOR
• 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: 11040303
• MDR Text Key: 222635369
• Report Number: 2124215-2020-23383
• 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: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 101574
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR