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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR
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GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number V272
Medical Device Problem Codes Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event 02/03/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
Boston scientific received information that this product was part of a system revision due to infection and erosion.Also, the pacemaker was used as temporary pacing device.There were no additional adverse patient effects reported.The product was explanted.
 
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Brand Name
INGENIO
Common Device Name
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
MDR Report Key5606817
Report Number2124215-2016-03432
Device Sequence Number11010169
Product Code NKE
UDI-Device Identifier00802526536663
UDI-Public(01)00802526536663(17)20160814
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/03/2016
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? No
Operator of Device Lay User/Patient
Device Expiration Date08/14/2016
Device Model NumberV272
Other Device ID NumberINTUA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2016
Initial Report FDA Received Date04/26/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
(B)(4)
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age88 YR
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