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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G547
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
Event Date 06/15/2023
Event Type  Injury  
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Additional information indicated that the patient also had bleeding or hematoma and wound dehiscence.This device along with the right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Additional information indicated that the patient also had bleeding or hematoma and wound dehiscence.This device along with the right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
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Brand Name
RESONATE HF 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
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 Key17210268
MDR Text Key317941318
Report Number2124215-2023-33390
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589744
UDI-Public00802526589744
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberG547
Device Catalogue NumberG547
Device Lot Number306650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age53 YR
Patient SexFemale
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