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); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was suspected to exhibit premature battery depletion (pbd).The device previously showed six years remaining longevity then during the recent check, the device showed two years remaining longevity.The battery diagnostic data indicated that the power consumption of this device has been increasing during the past year.The device should be replaced and returned for detailed analysis.The malfunction appeared consistent with other devices that have had continuous average power increases.As of this time, the device remains in service.No adverse patient effects reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was suspected to exhibit premature battery depletion (pbd).The device previously showed six years remaining longevity then during the recent check, the device showed two years remaining longevity.The battery diagnostic data indicated that the power consumption of this device has been increasing during the past year.The device should be replaced and returned for detailed analysis.The malfunction appeared consistent with other devices that have had continuous average power increases.Additional information indicated that the device was explanted due to premature battery depletion (pbd).No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Patient code 3191 captures the reportable event of surgery.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Patient code 3191 captures the reportable event of surgery.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.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.Boston scientific has issued a field safety notice regarding a subset of pacemakers in the accolade product family that has an elevated potential of exhibiting this behavior.This particular device was not included in the hydrogen induced premature depletion advisory population.However, this capacitor behavior can still occur in non-advisory devices.Appropriate term/code not available was used as there was no clinical symptoms observed.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was suspected to exhibit premature battery depletion (pbd).The device previously showed six years remaining longevity then during the recent check, the device showed two years remaining longevity.The battery diagnostic data indicated that the power consumption of this device has been increasing during the past year.The device should be replaced and returned for detailed analysis.The malfunction appeared consistent with other devices that have had continuous average power increases.Additional information indicated that the device was surgically explanted due to premature battery depletion (pbd).No additional adverse patient effects were reported.

• 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: 11183037
• MDR Text Key: 227529771
• Report Number: 2124215-2021-00766
• 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,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 701044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/17/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 03/02/2021
• Supplement Dates FDA Received: 01/22/2021; 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR