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

Model Number U125

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)

Patient Problem Muscle Stimulation (1412)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

It was reported that there was one jump in right ventricular (rv) lead pace impedance.The measurement was greater than 3000 ohms.Muscle noise oversensing occurred as a result of the impedance jump, as the pacing configuration automatically switched to unipolar pacing.The patient reported feeling stimulation.The health care professional (hcp) was going to bring the patient in for impedance testing.No adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.

Manufacturer Narrative

The evaluation conclusion code was updated.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 there was one jump in right ventricular (rv) lead pace impedance.The measurement was greater than 3000 ohms.Muscle noise oversensing occurred as a result of the impedance jump, as the pacing configuration automatically switched to unipolar pacing.The patient reported feeling stimulation.The health care professional (hcp) was going to bring the patient in for impedance testing.No adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.

• Brand Name: VALITUDE 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: 10236778
• MDR Text Key: 197815713
• Report Number: 2124215-2020-12545
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/17/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 703315
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR