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

Model Number U125

Device Problems Premature Discharge of Battery (1057); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely (low battery).The device was explanted and replaced.No additional adverse patient effects were reported.This product is not expected for return as it was disposed of at the facility.It was also noted that there was difficulty to advance the related lead, which occurred during the crt-p change out procedure.At this time no further information has been provided but has been requested.

Event Description

It was reported that during a routine upgrade procedure to replace the previous pacemaker for normal battery depletion, there were issues with the header of the new device.The related lead could not be properly connected/screwed into the header of the device.The pacemaker was exchanged for a new one, and the related lead was able to be connected to the new device without further issue.No adverse patient effects were reported.This product is not expected for return as it was disposed of at the facility.Additional information: the field representative clarified that this was a normal/upgrade procedure.The clinical observations made were related to header issues with the new pulse generator, which was attempted.

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.

• 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: 14734126
• MDR Text Key: 294277300
• Report Number: 2124215-2022-21905
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 717292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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