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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) lead, exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.Additional information received indicated that the patient was seen in clinic and the decision was made to continue monitoring the device to see if action was needed at a later date.This crt-p remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) lead, exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.Additional information received indicated that the patient was seen in clinic and the decision was made to continue monitoring the device to see if action was needed at a later date.This crt-p remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 11233711
• MDR Text Key: 228849312
• Report Number: 2124215-2021-02197
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 747595
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR