MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U128

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode, and the associated codes were 0xc 0xc 0xc.In addition, the patient was experience muscle stimulation.This crt-p was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 was applied to capture the reportable event of surgery.The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode, and the associated codes were 0xc 0xc 0xc.In addition, the patient experienced muscle stimulation.This crt-p was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11234051
• MDR Text Key: 228840751
• Report Number: 2124215-2020-29181
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 742135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR