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

Model Number U225

Device Problem High impedance (1291)

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

Event Date 12/20/2021

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) issued a lead safety switch (lss) alert in december 2021.The non-boston scientific right ventricular (rv) and left ventricular (lv) leads had a high, out-of-range pacing impedance measurement of greater than 3000 ohms on the date of the alert.Technical services requested complete device data, to review the impedance trend values from december, as the submitted data only included three months of measurements and there had been no other out-of-range values stored.Additionally, the available stored episodes did not reveal any noise or artifact on the rv or lv lead.Therefore, troubleshooting was recommended to try and provoke noise on the leads with patient movements and pocket manipulations.If no noise or jumps in impedance measurements could be produced, the pacing configurations on the rv and lv leads could be programmed back to the bipolar configuration.If testing produced impedance jumps, but no noise and sensing was appropriate, the leads could be programmed to unipolar pacing and bipolar sensing.As the out-of-range impedances were detected on the same day for both leads, it is likely that the lv lead was programmed to an extended bipolar configuration, which includes the rv lead as a pacing electrode.It was suggested to program the lv lead in a true bipolar configuration (rather than extended bipolar) to prevent a lead safety switch on the lv lead in case of high impedances on the rv lead.No adverse patient effects were reported.The sales representative reported that at this time, no further troubleshooting was performed and no reprogramming was done.The physician was only seeking information on how the lead safety switch algorithm worked and what they should consider at future follow ups.The device and competitors leads remain implanted and in service.

Manufacturer Narrative

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

• Brand Name: VISIONIST 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: 14742933
• MDR Text Key: 294386087
• Report Number: 2124215-2022-22017
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2020
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 710903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1