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 09/21/2019

Event Type  malfunction  

Manufacturer Narrative

The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead exhibited high out of range pacing impedance measurements greater than 2,000 ohms resulting in activation of the lead safety switch (lss) feature.The patient experienced phrenic stimulation with unipolar pacing.Sensing and threshold measurements were noted to be stable.The configuration was programmed back to bipolar and pacing impedance measurements were noted to be within normal limits at 1,500 ohms.Subsequently, another out of range measurement was recorded and again resulted in activation of the lss feature.A health care professional (hcp) planned to schedule the patient for an in clinic follow up for further evaluation.Available information indicates that this product remains implanted and in service.No adverse patient effects were reported.

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 the root cause of the out of range measurements was not determined.The lv lead configuration was reprogrammed and monitoring will be continued.

• 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: 9204514
• MDR Text Key: 162784701
• Report Number: 2124215-2019-21326
• 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
• Report Date: 01/07/2020

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: 09/24/2020
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 736187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR