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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE; SUBCUTANEOUS DEFIB ELECTRODE
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE; SUBCUTANEOUS DEFIB ELECTRODE Back to Search Results
Model Number 3501
Device Problems Failure to Read Input Signal (1581); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/15/2023
Event Type  malfunction  
Event Description
It was reported the physician saw a lower signal amplitude via the latitude remote patient monitoring system, and a follow-up and x-ray of this subcutaneous implantable cardioverter defibrillator (s-icd) system were performed.The follow-up confirmed a morphology change and lower amplitude.Impedance was in range and stable.The x-ray suggested both an electrode and device dislodgement.The physician noted the patient had a liquid secretion and accumulation in the pocket and lead zone after implant, although there was no confirmation of infection.The physician suspected this caused the stitches to loosen.The device was reprogrammed to secondary vector, and a system revision will be performed in the coming days.No adverse patient effects were reported.This s-icd system remains in service.
 
Event Description
It was reported the physician saw a lower signal amplitude via the latitude remote patient monitoring system, and a follow-up and x-ray of this subcutaneous implantable cardioverter defibrillator (s-icd) system were performed.The follow-up confirmed a morphology change and lower amplitude.Impedance was in range and stable.The x-ray suggested both an electrode and device dislodgement.The physician noted the patient had a liquid secretion and accumulation in the pocket and lead zone after implant, although there was no confirmation of infection.The physician suspected this caused the stitches to loosen.The device was reprogrammed to secondary vector, and a system revision will be performed in the coming days.No adverse patient effects were reported.This s-icd system remains in service.To date, no additional information has been received.Should additional follow-up information be provided in the future, an updated report will be issued.
 
Manufacturer Narrative
To date, boston scientific has not received confirmation of whether or not a system revision has been performed, and neither the s-icd nor the electrode have been returned for technical analysis.Without a returned product it is not possible to definitively confirm how it may have contributed to the complaint incident.If pertinent information is provided in the future, an updated report will be submitted.
 
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Brand Name
EMBLEM S-ICD ELECTRODE
Type of Device
SUBCUTANEOUS DEFIB ELECTRODE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key17020821
MDR Text Key316880238
Report Number2124215-2023-27193
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P110042/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3501
Device Catalogue Number3501
Device Lot Number230793
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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