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

Model Number U125

Device Problems Signal Artifact/Noise (1036); Battery Problem (2885)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited noise and a battery drop.The battery life of this device dropped from ten years to six years in the last year.In addition, the clinician was not able to reproduce the noise with isometrics.The recent device data was reviewed and noted right ventricular output up to 5v and power consumption at 57uw.Boston scientific technical services (ts) further discussed due to lead noise there could be intermittent loss of capture and increased output.Subsequently, this device was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed in which allegation made were not confirmed.The baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.In addition, the device passed all pin gauge tests per procedure and was subjected to and passed all automated therapy verification testing which confirms proper operation of the pacing, sensing, and shocking functions of the device.Further, the visual inspection found no anomalies and device passed the mechanical/electrical testing.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited noise and a battery drop.The battery life of this device dropped from ten years to six years in the last year.In addition, the clinician was not able to reproduce the noise with isometrics.The recent device data was reviewed and noted right ventricular output up to 5v and power consumption at 57uw.Boston scientific technical services (ts) further discussed due to lead noise there could be intermittent loss of capture and increased output.Subsequently, this device was explanted.No additional adverse patient effects were reported.

• Brand Name: VALITUDE 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11211706
• MDR Text Key: 228165443
• Report Number: 2124215-2021-01139
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2020
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 708789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male