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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
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BOSTON SCIENTIFIC CORPORATION INGENIO; PULSE-GENERATOR, SINGLE CHAMBER, SINGLE Back to Search Results
Model Number J172
Device Problem Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  Injury  
Event Description
It was reported that this pacemaker was found to be in safety mode.Device replacement was recommended.Additional information provided from the field indicated surgical intervention was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.This product is expected to be returned back from the field for analysis.This report will be updated upon completion of analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the device underwent detailed analysis.Visual inspection did not show any abnormalities.Review of the device memory confirmed it was in safety mode.The battery was disconnected from the hybrid assembly and testing indicated the battery voltage was normal.With any hardware being ruled out for the point of failure, it was determined that a form of software corruption had caused the device to enter safety core.The root cause of the software corruption in this device could not be established.
 
Event Description
It was reported that this pacemaker was found to be in safety mode.Device replacement was recommended.Additional information provided from the field indicated surgical intervention was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.
 
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Brand Name
INGENIO
Type of Device
PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key12113344
MDR Text Key260266463
Report Number2124215-2021-14281
Device Sequence Number1
Product Code LWW
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/05/2016
Device Model NumberJ172
Device Catalogue NumberJ172
Device Lot Number109783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Hospitalization; Required Intervention;
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