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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD Back to Search Results
Model Number 4480
Device Problems Over-Sensing (1438); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  malfunction  
Event Description
It was reported that the noise oversensing was noted on this right atrial (ra) lead.Increased pacing thresholds were also noted.The patient fell two months prior, and a lead dislocation was suspected.An xray is expected, and the devices vt zone was reprogrammed.Further follow-up is expected with xray results, and this ra lead remains in-service at this time.No adverse patient effects were reported.
 
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Brand Name
FINELINE II STEROX
Type of Device
IMPLANTABLE LEAD
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 Key19153241
MDR Text Key341364107
Report Number2124215-2024-24240
Device Sequence Number1
Product Code DTB
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4480
Device Catalogue Number4480
Device Lot Number710238
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2024
Initial Date FDA Received04/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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