MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION

Model Number U125

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2020

Event Type  malfunction  

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

It was reported that the device was at pre-implant and got the alert for voltage too low for projected remaining capacity related to fault code 1003.Per faults and actions, the pacemaker can not be implanted.No patient involvement.

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

It was reported that the device was at pre-implant and got the alert for voltage too low for projected remaining capacity related to the code 1003.Several months later, the data from the disk was reviewed.It was determined that the battery voltage is tracking the temperature, and has recovered with warmer temps.The code can be removed and the device can be implanted.No patient involvement at this time.

• Brand Name: VALITUDE CRT-P
• Type of Device: PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10253236
• MDR Text Key: 198196306
• Report Number: 2124215-2020-11382
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/11/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 712484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Patient Sequence Number: 1