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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALITY; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
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BOSTON SCIENTIFIC CORPORATION VITALITY; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) Back to Search Results
Model Number T180
Device Problem Interrogation Problem (4017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2018
Event Type  malfunction  
Event Description
It was reported that this implantable cardioverter defibrillator (icd) could not be interrogated despite trying two different programmers.The physician was made aware of this and there were no further actions noted.No adverse patient effects were reported.The device remains in service.
 
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Brand Name
VITALITY
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
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 Key8084548
MDR Text Key127579830
Report Number2124215-2018-61312
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960040/S053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/27/2007
Device Model NumberT180
Device Catalogue NumberT180
Device Lot Number206926
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age53 YR
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