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 INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
  • 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 INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G148
Device Problem High impedance (1291)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
Additional information is being requested from the field.If additional information is received this report will be updated.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator and non boston scientific right ventricular lead exhibited shock impedance measurements of greater than 200 ohms.The field representative was in the clinic and could not recreate impedance measurements.Then, a week later isometrics was performed and no out of range impedance measurements or noise could be reproduced.Technical services (ts) discussed additional troubleshooting options.The device remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator and non boston scientific right ventricular lead exhibited shock impedance measurements of greater than 200 ohms.The field representative was in the clinic and could not recreate impedance measurements.Then, a week later isometrics was performed and no out of range impedance measurements or noise could be reproduced.Technical services (ts) discussed additional troubleshooting options.The device remains in service.No adverse patient effects were reported.Additional information was received that the patient was induced three times in which shock impedance measurements were stable with a few excursions up and down.Technical services noted to continue to monitor.
 
Manufacturer Narrative
If additional information is received a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INOGEN X4 CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11105069
MDR Text Key225082133
Report Number2124215-2020-26514
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534591
UDI-Public00802526534591
Combination Product (y/n)N
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/20/2020
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number188807
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2020
Initial Date FDA Received01/02/2021
Supplement Dates Manufacturer Received08/02/2021
Supplement Dates FDA Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
-
-