Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY+; IMPLANTABLE LEAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INGEVITY+; IMPLANTABLE LEAD Back to Search Results
Model Number 7840
Device Problems Failure to Capture (1081); High impedance (1291); Difficult to Insert (1316); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
It was reported that this right atrial (ra) lead was an attempted implant due to loss of capture (loc) and high pacing impedances measures.The lead insertion was difficult as the vascular path of the patient was thin and vessel was astringent.Patient was not able to continue on the procedure while trying to get good readings from the lead.Implant procedure finished just with the right ventricular (rv) lead implanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Supplemental report was created to correct the following: h.Device manufacturers only.6.Adverse event problem: change in medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.10.Additional manufacturer narrative.Upon receipt at our post market quality assurance laboratory, visual inspection revealed lead tip curved.This type of damage is consistent with handling complications.
 
Event Description
It was reported that this right atrial (ra) lead was an attempted implant due to loss of capture (loc) and high pacing impedances measures.The lead insertion was difficult as the vascular path of the patient was thin and vessel was astringent.Patient was not able to continue on the procedure while trying to get good readings from the lead.Implant procedure finished just with the right ventricular (rv) lead implanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Correction e1 field: initial reporter phone updated.H6 field: device codes updated.Supplemental report was created to correct the following: h.Device manufacturers only 6.Adverse event problem: change in medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.10.Additional manufacturer narrative upon receipt at our post market quality assurance laboratory, visual inspection revealed lead tip curved.This type of damage is consistent with handling complications.
 
Event Description
It was reported that the right atrial (ra) lead showed to be not capturing and presented high impedances measures at the moment of implant because lead was damage when inserting it through patient thin and astringent vessel.Patient was not able to continue on the procedure while trying to get good readings from the lead.Implant procedure finished just with the right ventricular (rv) lead implanted.Device returned to boston scientific.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INGEVITY+
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11791645
MDR Text Key249520256
Report Number2124215-2021-13280
Device Sequence Number1
Product Code NVN
UDI-Device Identifier00802526604430
UDI-Public00802526604430
Combination Product (y/n)N
PMA/PMN Number
P150012/S083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/08/2022
Device Model Number7840
Device Catalogue Number7840
Device Lot Number1018598
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age31 YR
-
-