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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES
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BOSTON SCIENTIFIC CORPORATION INGEVITY MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES Back to Search Results
Model Number 7742
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
It was reported that during the procedure, this right ventricular (rv) lead exhibited unsatisfactory sensing parameters.The lead was replaced with a new one to complete the procedure.No adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was extended and dried blood was present around the helix.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the inner conductor coil had a break at the distal end of the terminal pin.Based upon the clinical observations and the laboratory findings, investigation found it likely that torsional overstress during attempts to extend/retract the helix caused the inner conductor coil to break.The identified break contributed to the reported clinical observations.
 
Event Description
It was reported that during the procedure, this right ventricular (rv) lead exhibited unsatisfactory sensing parameters.The lead was replaced with a new one to complete the procedure.No adverse patient effects were reported.This lead was received for product analysis.
 
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Brand Name
INGEVITY MRI
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 Key19068188
MDR Text Key339882390
Report Number2124215-2024-21348
Device Sequence Number1
Product Code NVN
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/08/2024
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 Number7742
Device Catalogue Number7742
Device Lot Number1229927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/19/2024
Initial Date FDA Received04/08/2024
Date Device Manufactured10/12/2023
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 SexFemale
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