MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problem High impedance (1291)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/11/2021

Event Type  malfunction  

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) and this left ventricular (lv) lead triggered a lead safety switch (lss) due to high out-of-range pace impedance measurements greater than 2,000 ohms.Following the switch to unipolar, the patient was experiencing undesired phrenic nerve stimulation.Technical services (ts) reviewed programming options.Additional information received indicated that the vector was changed to one without phrenic nerve stimulation, and the lv impedance alert value was increased to 2,500 ohms.This crt-p and lv lead remain in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and this left ventricular (lv) lead triggered a lead safety switch (lss) due to high out-of-range pace impedance measurements greater than 2,000 ohms.Following the switch to unipolar, the patient was experiencing undesired phrenic nerve stimulation.Technical services (ts) reviewed programming options.Additional information received indicated that the vector was changed to one without phrenic nerve stimulation, and the lv impedance alert value was increased to 2,500 ohms.This crt-p and lv lead remain in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Manufacturer Narrative

This supplemental was filled to correct fields h6: "evaluation result codes" and "impact codes" due to the stimulation as well as field h10 "additional mfr narrative".This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and this left ventricular (lv) lead triggered a lead safety switch (lss) due to high out-of-range pace impedance measurements greater than 2,000 ohms.Following the switch to unipolar, the patient was experiencing undesired phrenic nerve stimulation.Technical services (ts) reviewed programming options.Additional information received indicated that the vector was changed to one without phrenic nerve stimulation, and the lv impedance alert value was increased to 2,500 ohms.This crt-p and lv lead remain in service.No 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: 11698294
• MDR Text Key: 246450613
• Report Number: 2124215-2021-09216
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2022
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 751026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR