MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U125

Device Problems Failure to Capture (1081); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) and another manufacturer's right atrial (ra) lead exhibited intermittent increases in pacing impedance measurements and loss of capture (loc).An x-ray was taken which did not reveal any signs of a lead integrity issue.Boston scientific technical services (ts) discussed other reasons for these measurements, including possible slight movement of the lead in the header of the device.However, the physician still believed the intermittent high impedance and loss of capture (loc) were related to a lead issue and subsequently surgically abandoned the ra lead.A new lead was successfully implanted and no measurement issues were observed.The crt-p and new ra lead remain in service and no adverse patient effects were reported.

• Brand Name: VALITUDE CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9549971
• MDR Text Key: 174178765
• Report Number: 2124215-2019-27209
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 702322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR