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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; IMPLANTABLE LEAD Back to Search Results
Model Number 7741
Device Problems Difficult to Insert (1316); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Event Description
It was reported that this right atrial (ra) lead was attempted implant.Insulation kinking was noted when the lead was inserted through the introducer.A new ra lead was successfully placed.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.No adverse patient effects were reported.
 
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Brand Name
INGEVITY MRI
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 Key12749684
MDR Text Key280066759
Report Number2124215-2021-34181
Device Sequence Number1
Product Code NVN
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/18/2023
Device Model Number7741
Device Catalogue Number7741
Device Lot Number1202833
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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