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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE LEAD Back to Search Results
Device Problems Pocket Stimulation (1463); High Capture Threshold (3266)
Patient Problems Muscle Stimulation (1412); Chest Pain (1776); Dyspnea (1816); Cardiac Tamponade (2226); Cardiac Perforation (2513); No Code Available (3191)
Event Date 04/01/2007
Event Type  Injury  
Manufacturer Narrative
As no further information is expected this investigation is complete.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported via a study of 1359 patients who were implanted with cardiac devices.Of those patients, 15 experienced an right ventricular perforation.This population of the study group, was noted to have had patients with high thresholds and pocket stimulation noted.These leads were able to be repositioned successfully.No additional adverse patient effects were reported.
 
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Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key10757831
MDR Text Key213853054
Report Number2124215-2020-22615
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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