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); False Positive Result (1227)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy pacemaker exhibited a signal artifact monitor episode resulting in the respiratory rate trend sensor being disabled.Technical services noted this was due to the false positive detection of atrial fibrillation.The healthcare provider questioned if the battery of this pacemaker was depleting prematurely.A request was made to have data from this device analyzed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed that the battery appeared to be depleting more quickly than expected.The device was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker exhibited a signal artifact monitor episode resulting in the respiratory rate trend sensor being disabled.Technical services noted this was due to the false positive detection of atrial fibrillation.The healthcare provider questioned if the battery of this pacemaker was depleting prematurely.A request was made to have data from this device analyzed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed that the battery appeared to be depleting more quickly than expected.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.

• 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
• MDR Report Key: 11661729
• MDR Text Key: 245352254
• Report Number: 2124215-2021-05193
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 701437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0360-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR