MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A209

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited a battery depletion (bd) error after it was temporarily deactivated with a magnet during an unrelated surgery.Boston scientific technical services confirmed the s-icd data showed a large number of annunciator beeps equivalent to a full energy charge occurred the day of a battery measurement.This caused a low voltage and triggered the bd error.The battery had already recovered significantly and the error was reset.The s-icd remains in service and there were no adverse patient effects reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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: 9550743
• MDR Text Key: 174297718
• Report Number: 2124215-2019-26805
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S043
• 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: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/25/2019
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 219307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1