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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 0692
Device Problems Pocket Stimulation (1463); Device Dislodged or Dislocated (2923)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 02/15/2024
Event Type  malfunction  
Event Description
It was reported that this right ventricular (rv) lead may have dislodged and was causing the patient to feel a twitching sensation over the past year.No out-of-range measurements or noise was noted when testing the system.The rv lead remains in service at this time.No 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 Key18773656
MDR Text Key336305229
Report Number2124215-2024-10989
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Reporter Country CodeEI
PMA/PMN Number
P910073/S145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/30/2020
Device Model Number0692
Device Catalogue Number0692
Device Lot Number548242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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