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

Model Number U125

Device Problems Under-Sensing (1661); Use of Device Problem (1670)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right atrial (ra) lead, exhibited undersensing of atrial flutter.Every other beat was in refractory with some falling into blanking, resulting in a lack of mode switching.The arrhythmia was not chronic and converted while the patient was in the clinic.In addition, the atrial tachy response (atr) trigger rate was set to 150 bpm and the atrial flutter rate was slightly less at 145 bpm.It was noted that lowering the atr trigger rate to 140 bpm and decreasing atrial blanking after ventricular pace to 85 ms still did not allow mode switching.Technical services (ts) reviewed additional programming options.This crt-p remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right atrial (ra) lead, exhibited undersensing of atrial flutter.Every other beat was in refractory with some falling into blanking, resulting in a lack of mode switching.The arrhythmia was not chronic and converted while the patient was in the clinic.In addition, the atrial tachy response (atr) trigger rate was set to 150 bpm and the atrial flutter rate was slightly less at 145 bpm.It was noted that lowering the atr trigger rate to 140 bpm and decreasing atrial blanking after ventricular pace to 85 ms still did not allow mode switching.Technical services (ts) reviewed additional programming options.This crt-p remains in service.No adverse patient effects were reported.Additional information received reported that this crt-p was explanted and replaced due to normal battery depletion (nbd).No adverse patient effects were reported.

• 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
• 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: 17188127
• MDR Text Key: 317919032
• Report Number: 2124215-2023-32670
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2023

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: Lay User/Patient
• Device Expiration Date: 05/04/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 702565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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 Age: 61 YR
• Patient Sex: Female