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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 Device Displays Incorrect Message (2591)
Patient Problem Bradycardia (1751)
Event Date 11/16/2018
Event Type  Injury  
Manufacturer Narrative
No further information has been provided to date.This report will be updated should additional information become available.
 
Event Description
It was reported that the patient implanted with this device was found with a heart rate of 40 bpm.Upon interrogation, a code 1003 indicative of battery voltage too low for the projected remaining capacity was observed.Device replacement was recommended.This device remains in service.
 
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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 CLONMEL LIMITED
cashel road
,
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8324485
MDR Text Key135678225
Report Number2124215-2018-64398
Device Sequence Number1
Product Code LWW
Combination Product (y/n)N
Reporter Country CodeIN
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 02/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/21/2017
Device Model NumberJ172
Device Catalogue NumberJ172
Device Lot Number295471
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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