MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE

Model Number U128

Device Problems High impedance (1291); Pocket Stimulation (1463)

Patient Problem Muscle Stimulation (1412)

Event Date 06/23/2019

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and another manufacturer's right atrial (ra) lead exhibited a high out of range pacing impedance measurement greater than 2,000 ohms resulting in activation of the lead safety switch (lss) to unipolar pacing.The patient experienced pocket stimulation with the unipolar pacing.Subsequent pacing impedance measurements were noted to be stable and within normal limits.Boston scientific technical services (ts) discussed programming the configuration back bipolar pacing and sensing and continue monitoring.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and another manufacturer's right atrial (ra) lead exhibited a high out of range pacing impedance measurement greater than 2,000 ohms resulting in activation of the lead safety switch (lss) to unipolar pacing.The patient experienced pocket stimulation with the unipolar pacing.Subsequent pacing impedance measurements were noted to be stable and within normal limits.Boston scientific technical services (ts) discussed programming the configuration back bipolar pacing and sensing and continue monitoring.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.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8819360
• MDR Text Key: 152033740
• Report Number: 2124215-2019-14475
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 709549
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR