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

Model Number U125

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problems Syncope/Fainting (4411); Asystole (4442)

Event Date 10/23/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.It was noted that the patient was pacer dependent and experienced a syncopal episode due to pacing inhibition with greater than two seconds of asystole.As a result the patient was admitted to the hospital, and scheduled for a device replacement procedure.A temporary wire was placed to provide pacing during the procedure.The crt-p was explanted and replaced with another manufacturer's device.No additional adverse patient effects were reported.It was noted that the other manufacturer's sales representative indicated that the explanted crt-p was set aside for product return.

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.It was noted that the patient was pacer dependent and experienced a syncopal episode due to pacing inhibition with greater than two seconds of asystole.As a result the patient was admitted to the hospital, and scheduled for a device replacement procedure.A temporary wire was placed to provide pacing during the procedure.The crt-p was explanted and replaced with another manufacturer's device.No additional adverse patient effects were reported.It was noted that the other manufacturer's sales representative indicated that the explanted crt-p was set aside for product return.

Manufacturer Narrative

Updated d6b: explant date now known and populated ((b)(6) 2023).The product has been received for analysis.This report will be updated upon completion of analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Device telemetry data confirmed it was operating in safety mode/determined it had undergone resets and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.Updated d6b: explant date now known and populated ((b)(6) 2023).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.It was noted that the patient was pacer dependent and experienced a syncopal episode due to pacing inhibition with greater than two seconds of asystole.As a result the patient was admitted to the hospital, and scheduled for a device replacement procedure.A temporary wire was placed to provide pacing during the procedure.The crt-p was explanted and replaced with another manufacturer's device.No additional adverse patient effects were reported.It was noted that the other manufacturer's sales representative indicated that the explanted crt-p was set aside for product return.

• Brand Name: VALITUDE 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
• 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: 18081200
• MDR Text Key: 327475012
• Report Number: 2124215-2023-62325
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 702539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female