MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems High impedance (1291); Pacing Problem (1439); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that during a cardiac resynchronization therapy pacemaker (crt-p) implant procedure, non-boston scientific leads were implanted in the right atrium (ra), right ventricle (rv), and left ventricle (lv).The leads were positioned, tested, and secured.However, when connecting the leads to the boston scientific crt-p, the device did not automatically exit storage mode as expected and high, out-of-range pacing impedance measurements of greater than 3,000 ohms were observed on all three leads.The leads were disconnected, cleaned, and reconnected, ensuring proper insertion into the device ports, but the impedance issue could not be resolved.Additional troubleshooting was performed, including purging any air from the device header, using saline to lubricate the terminal pins, and ensuring there were no obstructions in the lead barrels.These efforts were repeated four times, but the issue persisted and a new device was provided to the physician and implanted successfully.No adverse patient effects were reported.The attempted device was expected to be returned for analysis.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The seal plugs were intact and the setscrews moved freely.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that during a cardiac resynchronization therapy pacemaker (crt-p) implant procedure, non-boston scientific leads were implanted in the right atrium (ra), right ventricle (rv), and left ventricle (lv).The leads were positioned, tested, and secured.However, when connecting the leads to the boston scientific crt-p, the device did not automatically exit storage mode as expected and high, out-of-range pacing impedance measurements of greater than 3,000 ohms were observed on all three leads.The leads were disconnected, cleaned, and reconnected, ensuring proper insertion into the device ports, but the impedance issue could not be resolved.Additional troubleshooting was performed, including purging any air from the device header, using saline to lubricate the terminal pins, and ensuring there were no obstructions in the lead barrels.These efforts were repeated four times, but the issue persisted and a new device was provided to the physician and implanted successfully.No adverse patient effects were reported.The attempted device was expected to be returned for analysis.Additional information provided advised product has been shipped back for analysis.

• 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
• 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: 18393559
• MDR Text Key: 331712096
• Report Number: 2124215-2023-73646
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: TD
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: Health Professional
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 783783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male