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 02/25/2019

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 to boston scientific that a low voltage alert, code 1003, was recorded on this pacemaker pre-implant. 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. No 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8722906
• MDR Text Key: 148800484
• Report Number: 2124215-2019-12234
• Device Sequence Number: 1
• Product Code: NKE
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/18/2020
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 709703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/21/2019 Patient Sequence Number: 1