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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0672
Device Problems Pocket Stimulation (1463); High Capture Threshold (3266)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)
Event Date 03/06/2024
Event Type  Injury  
Event Description
It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on this recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on this recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
 
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Brand Name
RELIANCE 4-FRONT
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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 Key18984200
MDR Text Key338657984
Report Number2124215-2024-18400
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number0672
Device Catalogue Number0672
Device Lot Number206456
Was Device Available for Evaluation? No
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age59 YR
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