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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY+; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES
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BOSTON SCIENTIFIC CORPORATION INGEVITY+; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES Back to Search Results
Model Number 7842
Device Problems Difficult to Insert (1316); Off-Label Use (1494); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
Event Description
It was reported that during an implant procedure this brady lead was attempted to be placed into the left bundle branch (lbb).Tissue was built up into the helix during lbb boring and the helix was bent.A different lead was successfully implanted and remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
If additional information is received, a supplemental report will be filed at that time.
 
Manufacturer Narrative
This lead was returned to our post market quality assurance laboratory with the helix mechanism in an extended position.Visual inspection found dried blood/tissue around the helix.Subsequent testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported helix extension/retraction problems.
 
Event Description
It was reported that during an implant procedure this brady lead was attempted to be placed into the left bundle branch (lbb).Tissue was built up into the helix during lbb boring and the helix was bent.A different lead was successfully implanted and remains in service.No adverse patient effects were reported.
 
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Brand Name
INGEVITY+
Type of Device
DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES
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 Key14068453
MDR Text Key289063572
Report Number2124215-2022-07651
Device Sequence Number1
Product Code NVN
UDI-Device Identifier00802526604522
UDI-Public00802526604522
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150012/S083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/09/2024
Device Model Number7842
Device Catalogue Number7842
Device Lot Number1074201
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2022
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 Age76 YR
Patient SexMale
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