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

Model Number U125

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that prior to implant, this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.The device was not an attempted implant; therefore, there was no patient involved.A different device was successfully implanted, and this device was returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the clinically observed error message was reproduced.Memory review confirmed that the device underwent a reset due to memory corruption which resulted in the observed error message.Following the reset, the device reverted to a safety mode with limited programmability, in which single chamber pacing and defibrillation therapy were available.The cause of the memory corruption could not be confirmed.

Event Description

This report is being filed to provide product investigation results.

• 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
• MDR Report Key: 8523076
• MDR Text Key: 142223306
• Report Number: 2124215-2019-05249
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/15/2020
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 711399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1