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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D142
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Unspecified Infection (1930); Swelling (2091); No Code Available (3191); Pericardial Effusion (3271)
Event Date 08/14/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.Reportedly, the patient was presented in the hospital with the date unknown related to dyspnea.Subsequently, echo was done, and patient was diagnosed with pericardial effusion.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The icd was explanted.
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) had an infection.Reportedly, the patient was presented in the hospital with the date unknown related to dyspnea.Subsequently, echo was done, and patient was diagnosed with pericardial effusion.In addition, a revision was performed and the icd along with the right atrial (ra) lead and right ventricular (rv) lead were explanted.It was confirmed by the physician that there was an infection.The patient was treated with intravenous antibiotics.The explanted products were sent to pathology and send to electrophysiology (ep) lab and will be returned.No additional adverse patient effects were reported.
 
Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Patient code 3191 captures the reportable event of surgery and the additional intervention treatment with the use of intravenous antibiotics.Correction on patient code.
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) had an infection.Reportedly, the patient was presented in the hospital with the date unknown related to dyspnea.Subsequently, echo was done, and patient was diagnosed with pericardial effusion.In addition, a revision was performed and the icd along with the right atrial (ra) lead and right ventricular (rv) lead were explanted.It was confirmed by the physician that there was an infection.The patient was treated with intravenous antibiotics.No additional adverse patient effects were reported.The explanted products were sent to pathology and send to electrophysiology (ep) lab and will be returned.
 
Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Patient code 3191 captures the reportable event of surgery and the additional intervention treatment with the use of intravenous antibiotics.
 
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Brand Name
INOGEN EL ICD DR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key10723268
MDR Text Key212678962
Report Number2124215-2020-21541
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526534249
UDI-Public00802526534249
Combination Product (y/n)N
PMA/PMN Number
P960040/S306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/27/2022
Device Model NumberD142
Device Catalogue NumberD142
Device Lot Number577501
Was Device Available for Evaluation? No
Date Manufacturer Received08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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