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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALITY 2 VR PROGRAMMER, PACEMAKER

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BOSTON SCIENTIFIC CORPORATION VITALITY 2 VR PROGRAMMER, PACEMAKER Back to Search Results
Model Number T175
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Unspecified Infection (1930)
Event Date 04/01/2015
Event Type  Death  
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 Description

It was reported in a journal article that the patient implanted with this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead experienced a pocket infection and/or vegetation on the lead. The system was explanted and the icd was resterilized for use as an external icd. A new defibrillation lead was implanted and the resterilized device was connected. The device was programmed to offer brady pacing and defibrillation therapy with a cold can shocking configuration. This was intended to be used until the infection was resolved and a new system could be implanted. However, this patient died ten days after the system was explanted, before a new system could be placed. The journal article noted that although the systemic infection was not resolved despite a specific antibiotic regimen, the external icd seemed to play no role in the patient's death.

 
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Brand NameVITALITY 2 VR
Type of DevicePROGRAMMER, PACEMAKER
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 Key8000098
MDR Text Key124839062
Report Number2124215-2018-60421
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberT175
Device Catalogue NumberT175
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/24/2018 Patient Sequence Number: 1
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