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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION PERCIVA ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number D400
Device Problems Failure to Convert Rhythm (1540); Defective Device (2588); Interrogation Problem (4017)
Patient Problems Cardiac Arrest (1762); Electric Shock (2554)
Event Date 03/25/2023
Event Type  Injury  
Event Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced cardiac arrest.The patient needed to be externally resuscitated and was treated in a hospital setting and hospitalized in the icu.It was noted this device was unable to be interrogated.No magnet response was found.Different programmers were used, however, interrogation of the device was not successful.A device system revision is scheduled in the near future.No additional adverse patient effects were reported.At this time, this device system remains in service.
 
Event Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced cardiac arrest.The device delivered an electric shock, however, it was not successful.The patient needed to be externally resuscitated and was treated in a hospital setting and hospitalized in the icu.It was noted this device was unable to be interrogated.No magnet response was found.Different programmers were used, however, interrogation of the device was not successful.A device system revision is scheduled in the near future.Additional information was received that a device changeout procedure was performed and this device was explanted and replaced.During the procedure, the non boston scientific right ventricular (rv) lead was tested and out of range pacing impedance measurements were obtained.Visual inspection confirmed a lead fracture.This lead was capped and a new lead was implanted.No additional adverse patient effects were reported.
 
Event Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced cardiac arrest.The device delivered an electric shock, however, it was not successful.The patient needed to be externally resuscitated and was treated in a hospital setting and hospitalized in the icu.It was noted this device was unable to be interrogated.No magnet response was found.Different programmers were used, however, interrogation of the device was not successful.A device system revision is scheduled in the near future.Additional information was received that a device changeout procedure was performed and this device was explanted and replaced.During the procedure, the non boston scientific right ventricular (rv) lead was tested and out of range pacing impedance measurements were obtained.Visual inspection confirmed a lead fracture.This lead was capped and a new lead was implanted.No additional adverse patient effects were reported.This device has been received for analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher than normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.
 
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Brand Name
PERCIVA ICD VR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key16659458
MDR Text Key312489578
Report Number2124215-2023-15321
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526587863
UDI-Public00802526587863
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960040/S385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/07/2021
Device Model NumberD400
Device Catalogue NumberD400
Device Lot Number109889
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2019
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; Life Threatening; Required Intervention;
Patient Age46 YR
Patient SexFemale
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