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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE DEVICE Back to Search Results
Model Number K172
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This device remains in possession of the explanting hospital.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event or Problem Description
It was reported that this pacemaker was explanted due to exhibiting a high out of range pace impedance measurement.No additional adverse patient effects were reported.
 
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Brand Name
INGENIO
Common Device Name
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8050237
Report Number2124215-2018-61520
Device Sequence Number1585517
Product Code LWP
UDI-Device Identifier00802526516818
UDI-Public00802526516818
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
N970003/S132
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/08/2018
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
Operator of Device Lay User/Patient
Device Expiration Date08/27/2016
Device Model NumberK172
Device Catalogue NumberK172
Device Lot Number123100
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/25/2018
Initial Report FDA Received Date11/08/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age68 YR
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