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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G138
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191)
Event Date 03/26/2020
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.Reportedly, the pocket swabs were able to grow steph.The field representative was uncertain if the patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.Reportedly, the pocket swabs were able to grow steph.The field representative was uncertain if the patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.Additional information indicates that the patient also had staphylococcus aureus.There were no additional adverse patient effects reported.The crt-d was explanted.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Patient code 3191 is being used to capture the additional intervention performed and captures the reportable event of surgery.The cardiac resynchronization therapy defibrillator (crt-d) was returned.No analysis was performed as reported allegations of infection with sepsis were known inherent risk of device.This supplemental report is being filed to correct the entry in the h6: patient codes and patient code description and h10: additional mfr narrative.
 
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Brand Name
MOMENTUM X4 CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9995552
MDR Text Key188826828
Report Number2124215-2020-08826
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589188
UDI-Public00802526589188
Combination Product (y/n)N
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/26/2020
Device Model NumberG138
Device Catalogue NumberG138
Device Lot Number381449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Date Manufacturer Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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