MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)

Event Date 10/16/2018

Event Type  Injury  

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

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) was part of a system revision due to infection and erosion with sepsis.Additional information received from the field representative indicates that the pacemaker was explanted and then was used as an external temporary pacemaker.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-p remains in service.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 8180453
• MDR Text Key: 130883678
• Report Number: 2124215-2018-62417
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 725941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR