MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U128

Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 06/30/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered in safety mode.Technical services (ts) provided resolution option.It was noted that the patient sometimes feels pocket and muscle stimulation.The device was explanted and replaced.No adverse patient effects were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

Correction to field h6: impact codes.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered in safety mode.Technical services (ts) provided resolution option.It was noted that the patient sometimes feels pocket and muscle stimulation.The device was explanted and replaced.No adverse patient effects were reported.The device is expected to be returned for analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered in safety mode.Technical services (ts) provided resolution option.It was noted that the patient sometimes feels pocket and muscle stimulation.The device was explanted and replaced.No adverse patient effects were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

Correction to field d6b: explant date.

• Brand Name: VALITUDE X4 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: 17279075
• MDR Text Key: 318582896
• Report Number: 2124215-2023-35696
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 718991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male