MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems Premature Discharge of Battery (1057); High impedance (1291)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.An evaluation of the device was performed.Review of the device memory confirmed that a low voltage alert, code 1003, was recorded and that the device recorded low temperature readings prior to setting the low voltage alert.If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.This appears to be the case with this device.The battery did recover after the device was removed from the cold.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded a pre-implant 1003 code indicative of battery voltage too low for the projected remaining capacity, presumed to be due to cold weather.The device was not cleared for implant as data analysis indicated the device had a higher than usual left ventricular (lv) pacing threshold programmed.There is no patient involvement at the time of this issue.

• Brand Name: VALITUDE X4 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: 9926920
• MDR Text Key: 186725814
• Report Number: 2124215-2020-04580
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• 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
• Type of Report: Initial
• Report Date: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/06/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 746553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1