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

Model Number T175

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

The device was accidently discarded at the account/hospital and will not be returned for analysis.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 that this implantable cardioverter defibrillator (icd) had a battery status of middle of life 2 (mol2) in april but declared end of life (eol) seven months later.There was a concern that the device was depleting faster than expected.The device was explanted without incident.

• Brand Name: VITALITY 2
• Type of Device: PROGRAMMER, 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 Key: 8214126
• MDR Text Key: 131975631
• Report Number: 2124215-2018-62788
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P960040/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2011
• Device Model Number: T175
• Device Catalogue Number: T175
• Device Lot Number: 141828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention